FDA implementation of standards developed by the International conference on harmonisation

Food and Drug Law Journal

Volumn 52, Issue 2, 1997, Pages 203-223

  Booth, Paul M ^a  

^a FOLEY AND LARDNER LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

BIOTECHNOLOGY; CLINICAL TRIAL; CONFERENCE PAPER; COST; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; FOOD AND DRUG ADMINISTRATION; JAPAN; LAW; POLICY; RESEARCH; STANDARD; UNITED STATES;

DRUG APPROVAL; EUROPEAN UNION; GUIDELINES; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL COOPERATION; JAPAN; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030953040     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (227)

1. Elizabeth M. Rutherford, The FDA and "Privatization" - The Drug Approval Process, 50 FOOD & DRUG L.J. 203, 203 n.2 (1995) (citing PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA, MODERN MEDICINES: SAVING LIVES AND MONEY 4 (1994)).
2. Elizabeth M. Rutherford, The FDA and "Privatization" - The Drug Approval Process, 50 FOOD & DRUG L.J. 203, 203 n.2 (1995) (citing PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA, MODERN MEDICINES: SAVING LIVES AND MONEY 4 (1994)).
3. For a comparison of the drug approval processes in the United States, Europe, and Japan, see Rosemarie Kanusky, Note, Pharmaceutical Harmonization: Standardizing Regulations Among the United States, the European Community, and Japan, 16 HOUS. J. INT'L L. 665 (1994).
4. The cosponsors include the Food and Drug Administration (United States), the Pharmaceutical and Research Manufacturers Association (United States), the European Commission-European Union (Europe), the European Federation of Pharmaceutical Industries' Associations (Europe), the Ministry of Health and Welfare (Japan), and the Japan Pharmaceutical Manufacturers Association (Japan). In addition, the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) participates as an "umbrella" organization and provides the ICH Secretariat, which is located in Geneva, Switzerland. ICH also has accorded "observer" status to the World Health Organization, the European Free Trade Area, and the Canadian Health Protection Branch.
5. PROCEEDINGS OF THE SECOND INTERNATIONAL CONFERENCE ON HARMONIZATION ORLANDO 1993, at 1 (P.F. D'Arcy & D.W.G. Harron eds, 1994) [hereinafter SECOND ICH PROCEEDINGS].
6. Press Release, ICH Secretariat (Dec. 1, 1995) (Contact; ICH Coordinator, Pharmaceutical Research and Manufacturers of America, 7021 Enterprise Ave., McLean, VA 22101 (703) 442-0497).
7. Pub. L. No. 92-463, 86 Stat. 770 (1972) (codified at 5 U.S.C. App. §§ 1-15 (1994)).
8. SECOND ICH PROCEEDINGS, supra note 4, at 1.
9. A senior FDA official stated as the end of the third ICH: "We've just stepped up close to the realization of a dream. A dream: we can say it's a global dossier, which is available through any country in the world, or is acceptable to any regulatory authority in the world." ICH - A Great Success - Part II, DAILY NEWS BIOTECH. & MED. TECH., Dec. 11, 1995 (online news service) (remarks by Dr. Roger Williams, Assoc. Dir., Sci. and Med. Affairs, Center for Drug Evaluation and Research (CDER), FDA.
10. Each member region will continue to assess the safety and efficacy of a drug according to its own internal standards.
11. ICH produces guidelines that encompass both procedural requirements for review, such as the proper management of clinical trials, and substantive standards for review, such as standards for drug stability. See infra note 17.
12. For more complete reviews of the ICH process and comparisons of the regulatory frameworks in the United States, Europe, and Japan, see Teresa Pechulis Buono, Note, Biotechnology-Derived Pharmaceuticals: Harmonizing Regional Regulations, 18 SUFFOLK TRANSNAT'L L. REV. 133 (1995); Joseph G. Contrera, Note, The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become?, 8 ADMIN. L.J. AM. U, 927 (1995); David W. Jordan, Note, International Regulatory Harmonization: A New Era in Prescription Drug Approval, 25 VAND. J. TRANSNAT'L L. 471 (1992); Kanusky, supra note 2; Julie C. Relihan, Note, Expediting FDA Approval of AIDS Drugs: An International Approach, 13 B.U. INT'L L.J. 229 (1995).
13. For more complete reviews of the ICH process and comparisons of the regulatory frameworks in the United States, Europe, and Japan, see Teresa Pechulis Buono, Note, Biotechnology-Derived Pharmaceuticals: Harmonizing Regional Regulations, 18 SUFFOLK TRANSNAT'L L. REV. 133 (1995); Joseph G. Contrera, Note, The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become?, 8 ADMIN. L.J. AM. U, 927 (1995); David W. Jordan, Note, International Regulatory Harmonization: A New Era in Prescription Drug Approval, 25 VAND. J. TRANSNAT'L L. 471 (1992); Kanusky, supra note 2; Julie C. Relihan, Note, Expediting FDA Approval of AIDS Drugs: An International Approach, 13 B.U. INT'L L.J. 229 (1995).
14. For more complete reviews of the ICH process and comparisons of the regulatory frameworks in the United States, Europe, and Japan, see Teresa Pechulis Buono, Note, Biotechnology-Derived Pharmaceuticals: Harmonizing Regional Regulations, 18 SUFFOLK TRANSNAT'L L. REV. 133 (1995); Joseph G. Contrera, Note, The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become?, 8 ADMIN. L.J. AM. U, 927 (1995); David W. Jordan, Note, International Regulatory Harmonization: A New Era in Prescription Drug Approval, 25 VAND. J. TRANSNAT'L L. 471 (1992); Kanusky, supra note 2; Julie C. Relihan, Note, Expediting FDA Approval of AIDS Drugs: An International Approach, 13 B.U. INT'L L.J. 229 (1995).
15. For more complete reviews of the ICH process and comparisons of the regulatory frameworks in the United States, Europe, and Japan, see Teresa Pechulis Buono, Note, Biotechnology-Derived Pharmaceuticals: Harmonizing Regional Regulations, 18 SUFFOLK TRANSNAT'L L. REV. 133 (1995); Joseph G. Contrera, Note, The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become?, 8 ADMIN. L.J. AM. U, 927 (1995); David W. Jordan, Note, International Regulatory Harmonization: A New Era in Prescription Drug Approval, 25 VAND. J. TRANSNAT'L L. 471 (1992); Kanusky, supra note 2; Julie C. Relihan, Note, Expediting FDA Approval of AIDS Drugs: An International Approach, 13 B.U. INT'L L.J. 229 (1995).
16. For more complete reviews of the ICH process and comparisons of the regulatory frameworks in the United States, Europe, and Japan, see Teresa Pechulis Buono, Note, Biotechnology-Derived Pharmaceuticals: Harmonizing Regional Regulations, 18 SUFFOLK TRANSNAT'L L. REV. 133 (1995); Joseph G. Contrera, Note, The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become?, 8 ADMIN. L.J. AM. U, 927 (1995); David W. Jordan, Note, International Regulatory Harmonization: A New Era in Prescription Drug Approval, 25 VAND. J. TRANSNAT'L L. 471 (1992); Kanusky, supra note 2; Julie C. Relihan, Note, Expediting FDA Approval of AIDS Drugs: An International Approach, 13 B.U. INT'L L.J. 229 (1995).
17. The Steering Committee is composed of 14 members, with the six cosponsors providing two members each, plus two members nominated by IFPMA. The chair of the Committee rotates, and is determined by the country in which a Committee meeting takes place. Meetings are held two to three times per year. See Background to the Second International Conference on Harmonisation, in SECOND ICH PROCEEDINGS, supra note 4, at 1.
18. EWGs are composed of experts nominated by ICH cosponsors. EWGs meet at the same time as the Committee, and also have additional drafting meetings. Attendance at EWG meetings varies depending on the topic under discussion. Id.
19. An EWG is supposed to identify the "principle objectives" of each harmonization initiative that it proposes. These objectives include drafting Guidelines, encouraging mutual acceptance of the scientific validity of Guidelines and practices in "other regions," changing the interpretation and application of scientific requirements to improve harmonization, and changing the regulations to harmonize requirements that have a statutory basis. Id. This last objective thus appears to contemplate that ICH members will seek changes in their respective laws when necessary to achieve a harmonization objective. FDA believes, however, that it can adopt the finalized, harmonized Guidelines without any changes to the applicable statutes, and without following the notice-and-comment rulemaking requirements of the Administrative Procedures Act. See infra Part IV.C.
20. The comment period provided for in Federal Register notices relating to ICH published by FDA varies between four and 12 weeks.
21. Letter from Linda Horton, Director, International Policy, Food and Drug Administration, to Paul M. Booth (Feb. 20, 1996) (on file with author). FDA's methods of implementing the documents into the U.S. regulatory scheme by way of guidelines is discussed in more detail below. See infra Part IV.C.
22. See, e.g., SECOND ICH PROCEEDINGS, supra note 4, at 22 (keynote address by Dr. David A. Kessler, Comm'r of Food and Drugs, FDA).
23. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
24. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
25. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
26. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
27. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
28. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
29. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
30. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
31. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
32. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
33. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
34. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
35. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
36. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
37. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
38. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61
39. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
40. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
41. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
42. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
43. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
44. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
45. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
46. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
47. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
48. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
49. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
50. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
51. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
52. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
53. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
54. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
55. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
56. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995);
57. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
58. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
59. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
60. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
61. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
62. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
63. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
64. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
65. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
66. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
67. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
68. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
69. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
70. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
71. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
72. Draft Guideline on Impurities: Residual Solvents, 62 Fed. Reg. 24,302 (May 2, 1997); Draft Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 62 Fed. Reg. 24,312 (May 2, 1997); Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 62 Fed. Reg. 24,320 (May 2, 1997); Draft Guideline for the Preclinical Testing of Biotechnology-Derived Pharmaceutical, 62 Fed. Reg. 16,438 (Apr. 4, 1997); Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, 62 Fed. Reg. 16,026 (Apr. 3, 1997); Draft Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on the Limit Dose, 62 Fed. Reg. 15,715 (Apr. 2, 1997); Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports, 61 Fed. Reg. 51,287 (Oct. 1, 1996); Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals, 61 Fed. Reg. 43,298 (Aug. 21, 1996); Guideline on Structure and Content of Clinical Study Reports, 61 Fed. Reg. 37,320 (July 17, 1996); Final Guideline on Stability Testing of Biotechnological/Biological Products, 61 Fed. Reg. 36,466 (July 10, 1996); Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 61 Fed. Reg. 21,882 (May 10, 1996); Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, 61 Fed. Reg. 18,198 (Apr. 24, 1996); Guideline on Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility, 61 Fed. Reg. 15,360 (Apr. 5, 1996); Draft Guideline on Impurities in New Drug Products, 61 Fed. Reg. 11,268 (Mar. 19, 1996); Draft Guideline for the Photostability Testing of New Drug Substances and Products, 61 Fed. Reg. 9310 (Mar. 7, 1996); Draft Guideline on the Validation of Analytical Procedures: Methodology, 61 Fed. Reg. 9316 (Mar, 7, 1996); Draft Guideline on Stability Testing for New Dosage Forms, 61 Fed. Reg. 9060 (Mar. 6, 1996); Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals, 61 Fed. Reg. 81,546 (Mar. 1, 1996); Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, 61 Fed. Reg. 7006 (Feb. 23, 1996); Guideline on Impurities in New Drug Substances, 61 Fed. Reg. 372 (Jan. 4, 1996); Draft Guideline on Structure and Content of Clinical Study Reports, 60 Fed. Reg. 43,910 (Aug. 23, 1995); Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products, 60 Fed. Reg. 43,496 (Aug. 21, 1995); Draft Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals, 60 Fed. Reg. 43,498 (Aug. 21, 1995); Draft Guideline on Detection of Toxicity to Reproduction, 60 Fed. Reg. 43,500 (Aug. 21, 1995); Draft Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, 60 Fed. Reg. 43,501 (Aug. 21, 1995); Draft Guideline on Good Clinical Practice, 60 Fed. Reg. 42,948 (Aug. 17, 1995); Final Guideline: Validation of Analytical Procedures, 60 Fed. Reg. 11,260 (Mar. 1, 1995); Final Guideline.
73. Policy on Standards, 60 Fed. Reg, 53,078 (Oct. 11, 1995); International Memoranda of Understanding, New Compliance Policy Guide, 60 Fed. Reg. 31,485 (June 15, 1995); International Scientific Conference on Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products, 60 Fed. Reg. 25,920 (May 15, 1995).
74. Policy on Standards, 60 Fed. Reg, 53,078 (Oct. 11, 1995); International Memoranda of Understanding, New Compliance Policy Guide, 60 Fed. Reg. 31,485 (June 15, 1995); International Scientific Conference on Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products, 60 Fed. Reg. 25,920 (May 15, 1995).
75. Policy on Standards, 60 Fed. Reg, 53,078 (Oct. 11, 1995); International Memoranda of Understanding, New Compliance Policy Guide, 60 Fed. Reg. 31,485 (June 15, 1995); International Scientific Conference on Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products, 60 Fed. Reg. 25,920 (May 15, 1995).
76. See 59 Fed. Reg. 8648 (Feb. 23, 1994). The announcement states that the workshop was to be held on February 23, 1994. Since that meeting FDA has issued 30 Federal Register notices regarding ICH Guidelines, but no additional meetings have been held, and no comments on results from the meeting have been published.
77. SECOND ICH PROCEEDINGS, supra note 4, at 24. Outside of the ICH context, FDA also published draft guidelines for modifying the regulation of certain pharmaceutical biotechnology products to bring the agency's regulatory treatment more in line with that of traditional pharmaceuticals. 60 Fed. Reg, 63,048 (Dec. 8, 1995). This is relevant to the harmonization process because Commissioner Kessler identified the regulation of biotechnology-derived drugs as an area that is less developed than traditional pharmaceuticals, therefore allowing regulatory harmonization to begin with a "clean slate," See SECOND ICH PROCEEDINGS, supra note 4, at 24.
78. SECOND ICH PROCEEDINGS, supra note 4, at 24. Outside of the ICH context, FDA also published draft guidelines for modifying the regulation of certain pharmaceutical biotechnology products to bring the agency's regulatory treatment more in line with that of traditional pharmaceuticals. 60 Fed. Reg, 63,048 (Dec. 8, 1995). This is relevant to the harmonization process because Commissioner Kessler identified the regulation of biotechnology-derived drugs as an area that is less developed than traditional pharmaceuticals, therefore allowing regulatory harmonization to begin with a "clean slate," See SECOND ICH PROCEEDINGS, supra note 4, at 24.
79. The Senate heard testimony on the Food and Drug Administration Performance and Accountability Act of 1995 during February 1996. See S. 1477, 104th Cong., 1st Sess. (1995). A bill also was introduced into the House of Representatives during 1995: the FDA Modernization Act of 1995. H.R. 1742, 104th Cong., 1st Sess. (1995). S. 1477 was approved by the Labor and Human Resources Committee on a 12-to-4 bipartisan vote, but did not reach the floor of the senate for a vote in the face of a threatened filibuster. 143 CONG. REC. S2762-03 (daily ed. Apr. 7, 1997) (statement of Sen. Jim Jeffords (R-VT)). For discussions of some the issues surrounding FDA reform, see Note, FDA Reform and the European Medicines Evaluation Agency, 108 HARV. L. REV. 2009 (1995); Rutherford, supra note 1.
80. The Senate heard testimony on the Food and Drug Administration Performance and Accountability Act of 1995 during February 1996. See S. 1477, 104th Cong., 1st Sess. (1995). A bill also was introduced into the House of Representatives during 1995: the FDA Modernization Act of 1995. H.R. 1742, 104th Cong., 1st Sess. (1995). S. 1477 was approved by the Labor and Human Resources Committee on a 12-to-4 bipartisan vote, but did not reach the floor of the senate for a vote in the face of a threatened filibuster. 143 CONG. REC. S2762-03 (daily ed. Apr. 7, 1997) (statement of Sen. Jim Jeffords (R-VT)). For discussions of some the issues surrounding FDA reform, see Note, FDA Reform and the European Medicines Evaluation Agency, 108 HARV. L. REV. 2009 (1995); Rutherford, supra note 1.
81. Richard F, Kingham, A Look at the Future of Harmonization and Mutual Recognition, RA Focus, Feb. 1996, at 5.
82. Study Says U.S. Has Better Barrier to Bad Drugs Then Europe, WASH. POST, Feb. 3, 1995, at A9.
83. Kingham, supra note 22.
84. The population of the European Union (EU) is approximately 345,000,000. Eric M. Katz, Europe's Centralized New Drug Procedures: Is the United States Prepared to Keep Pace?, 48 FOOD & DRUG L.J. 577 (1993). For detailed discussions on the workings of the EMEA, see id. See also Evelyne Friedel & Michael Freundlich, European Community Harmonization of the Licensing and Manufacturing of Medicinal Products, 49 FOOD & DRUG L.J. 141 (1994); Richard F. Kingham, Peter W.L. Bogaert, & Pamela S, Eddy, The New European Medicines Agency, 49 FOOD & DRUG L.J. 301 (1994); Colleen K. Ottoson, Note, Regulation of Biotechnology in the European Community: How Twelve Nations Are Transforming A Global Industry, 6 MD. J. INT'L L. & TRADE 255 (1992).
85. The population of the European Union (EU) is approximately 345,000,000. Eric M. Katz, Europe's Centralized New Drug Procedures: Is the United States Prepared to Keep Pace?, 48 FOOD & DRUG L.J. 577 (1993). For detailed discussions on the workings of the EMEA, see id. See also Evelyne Friedel & Michael Freundlich, European Community Harmonization of the Licensing and Manufacturing of Medicinal Products, 49 FOOD & DRUG L.J. 141 (1994); Richard F. Kingham, Peter W.L. Bogaert, & Pamela S, Eddy, The New European Medicines Agency, 49 FOOD & DRUG L.J. 301 (1994); Colleen K. Ottoson, Note, Regulation
86. The population of the European Union (EU) is approximately 345,000,000. Eric M. Katz, Europe's Centralized New Drug Procedures: Is the United States Prepared to Keep Pace?, 48 FOOD & DRUG L.J. 577 (1993). For detailed discussions on the workings of the EMEA, see id. See also Evelyne Friedel & Michael Freundlich, European Community Harmonization of the Licensing and Manufacturing of Medicinal Products, 49 FOOD & DRUG L.J. 141 (1994); Richard F. Kingham, Peter W.L. Bogaert, & Pamela S, Eddy, The New European Medicines Agency, 49 FOOD & DRUG L.J. 301 (1994); Colleen K. Ottoson, Note, Regulation of Biotechnology in the European Community: How Twelve Nations Are Transforming A Global Industry, 6 MD. J. INT'L L. & TRADE 255 (1992).
87. The population of the European Union (EU) is approximately 345,000,000. Eric M. Katz, Europe's Centralized New Drug Procedures: Is the United States Prepared to Keep Pace?, 48 FOOD & DRUG L.J. 577 (1993). For detailed discussions on the workings of the EMEA, see id. See also Evelyne Friedel & Michael Freundlich, European Community Harmonization of the Licensing and Manufacturing of Medicinal Products, 49 FOOD & DRUG L.J. 141 (1994); Richard F. Kingham, Peter W.L. Bogaert, & Pamela S, Eddy, The New European Medicines Agency, 49 FOOD & DRUG L.J. 301 (1994); Colleen K. Ottoson, Note, Regulation of Biotechnology in the European Community: How Twelve Nations Are Transforming A Global Industry, 6 MD. J. INT'L L. & TRADE 255 (1992).
88. The population of the European Union (EU) is approximately 345,000,000. Eric M. Katz, Europe's Centralized New Drug Procedures: Is the United States Prepared to Keep Pace?, 48 FOOD & DRUG L.J. 577 (1993). For detailed discussions on the workings of the EMEA, see id. See also Evelyne Friedel & Michael Freundlich, European Community Harmonization of the Licensing and Manufacturing of Medicinal Products, 49 FOOD & DRUG L.J. 141 (1994); Richard F. Kingham, Peter W.L. Bogaert, & Pamela S, Eddy, The New European Medicines Agency, 49 FOOD & DRUG L.J. 301 (1994); Colleen K. Ottoson, Note, Regulation of Biotechnology in the European Community: How Twelve Nations Are Transforming A Global Industry, 6 MD. J. INT'L L. & TRADE 255 (1992).
89. See, e.g., Woodrow Wirsig, My Blindness - and the FDA's, WALL ST. J., Mar. 11, 1996, at A14. But see, Thomas J. Moore, Sugar Coating a Bitter Pill, WASH. POST, Mar. 10, 1996, at C1 (arguing that FDA reform is "the most frightening effort to rollback safety and efficacy laws since federal regulation began in 1906"). In 1995, House and Senate bills were introduced to reform the drug approval process. Present and former FDA officials, including then-Commissioner Kessler, testified at the Senate hearings for one of these bills, S. 1477. The bill proposes to approve U.S. sale of a drug that has been approved in the EU or the United Kingdoms if FDA fails to meet review deadlines. See S. 1477, § 404, 104th Cong., 1st Sess (1995) (proposed amendments to section 743 of the Federal Food, Drug, and Cosmetic Act (FDCA)) S 1477 also proposes approval of a new use of an approved drug on receipt of a petition by the manufacturer showing that this use has existed in widespread clinical practice for five years. See id. § 407 (proposed amendment to section 749(b) of the FDCA).
90. See, e.g., Woodrow Wirsig, My Blindness - and the FDA's, WALL ST. J., Mar. 11, 1996, at A14. But see, Thomas J. Moore, Sugar Coating a Bitter Pill, WASH. POST, Mar. 10, 1996, at C1 (arguing that FDA reform is "the most frightening effort to rollback safety and efficacy laws since federal regulation began in 1906"). In 1995, House and Senate bills were introduced to reform the drug approval process. Present and former FDA officials, including then-Commissioner Kessler, testified at the Senate hearings for one of these bills, S. 1477. The bill proposes to approve U.S. sale of a drug that has been approved in the EU or the United Kingdoms if FDA fails to meet review deadlines. See S. 1477, § 404, 104th Cong., 1st Sess (1995) (proposed amendments to section 743 of the Federal Food, Drug, and Cosmetic Act (FDCA)) S 1477 also proposes approval of a new use of an approved drug on receipt of a petition by the manufacturer showing that this use has existed in widespread clinical practice for five years. See id. § 407 (proposed amendment to section 749(b) of the FDCA).
91. Commissioner Kessler defended FDA's record on new drug approvals in testimony before a Senate Committee hearing on proposed revisions to the FDCA. Dr. Kessler stated that [T]he average approval time for new drug applications (NDA) submitted to the agency in 1987 was 33 months. For NDAs submitted in 1992 the time had been reduced to 19 months. These improved approval times have been made possible by shortening the time for completion of most first reviews to only 12 months. In addition [the General Accounting Office] GAO found that by 1994, FDA review and approval times were faster than those in the United Kingdom -a country many critics like to cite as a way of doing things better and faster. Revitalizing New Product Development - From Clinical Trials Through Food and Drug Administration (FDA) Review: Hearings on S. 1477 Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (1996) (statement of David A. Kessler, Commissioner of Food and Drugs, FDA). In contrast, at the same hearing, Dr. Carl Peck (former Director of FDA'S Center for Drug Evaluation and Research, currently a professor at Georgetown University and Director of the Center for Drug Development Science) stated that the approval process could be sped up without compromis ing standards on safety and efficacy. Id. (statement of Carl C. Peck).
92. Commissioner Kessler defended FDA's record on new drug approvals in testimony before a Senate Committee hearing on proposed revisions to the FDCA. Dr. Kessler stated that [T]he average approval time for new drug applications (NDA) submitted to the agency in 1987 was 33 months. For NDAs submitted in 1992 the time had been reduced to 19 months. These improved approval times have been made possible by shortening the time for completion of most first reviews to only 12 months. In addition [the General Accounting Office] GAO found that by 1994, FDA review and approval times were faster than those in the United Kingdom - a country many critics like to cite as a way of doing things better and faster. Revitalizing New Product Development - From Clinical Trials Through Food and Drug Administration (FDA) Review: Hearings on S. 1477 Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (1996) (statement of David A. Kessler, Commissioner of Food and Drugs, FDA). In contrast, at the same hearing, Dr. Carl Peck (former Director of FDA'S Center for Drug Evaluation and Research, currently a professor at Georgetown University and Director of the Center for Drug Development Science) stated that the approval process could be sped up without compromis ing standards on safety and efficacy. Id. (statement of Carl C. Peck).
93. 60 Fed. Reg. at 53,078.
94. 21 C.F.R. § 10.95 (1996).
95. Pub. L. No. 92-463, §§ 10, 11, 86 Stat. at 774-75 (codified at 5 U.S.C. App. §§ 10, 11).
96. 60 Fed. Reg. at 53,078, The draft policy statement was published originally at 59 Fed. Reg. at 60,870.
97. 60 Fed Reg. at 53,084.
98. Id. at 53,078.
99. Id. at 53,081.
100. Id. at 53,080. "The Codex Alimentarius Commission is an international organization founded in 1962 to facilitate world trade in foods and to promote consumer protection." Id.
101. Id. The Food Chemicals Codex is intended to provide the food industry with "guidance for food grade materials and processes, and thus help elevate the quality of food and food chemicals in domestic and international trade." Id.
102. Id. at 53,081.
103. Id. at 53,078.
104. See Pub. L. 103-465, 108 Stat. 4813 (1994) (codified at 19 U.S.C. §§ 3501-3624 (1994)).
105. 60 Fed. Reg. at 53,079 (emphasis not in original but added in Draft Policy).
106. Id. (emphasis not in original but added in Draft Policy).
107. Id. The World Trade Organization (WTO) was established by the Uruguay Round of the GATT, All signatories to the GATT are members of the WTO. See Statement of Administrative Action, The Uruguay Round Agreements Act, Pub. L. No. 103-465, 108 Stat, 4813 (codified at 19 U.S.C. §§ 3501-3624).
108. Another set of international standards that impact the pharmaceutical industry are the ISO 9000 standards. ISO 9000 is a series of voluntary quality standards, initially promulgated in 1987, and subsequently revised by the International Standards Organization. Their purpose is to harmonize international quality standards. Product liability and competition have caused widespread adoption of ISO 9000 standards in the drug and medical device industries. FDA's current good manufacturing practices standards contain many of the same elements as the ISO 9000 standards and, therefore, a drug manufacturer would have to make relatively few changes in operating procedures to conform to ISO 9000. For a review of the development of ISO 9000 standards, see Anthony L. Young, An Overview of ISO 9000 Application to Drug, Medical Device, and Environmental Management Issues, 49 FOOD & DRUG L.J. 469 (1994).
109. OMB Circular No. A-119, 58 Fed. Reg. 57,643 (Oct. 26, 1993). The FDA Policy on Standards explicitly adopts the approach of the OMB Circular. See 60 Fed. Reg. at 53,084.
110. OMB Circular No. A-119, ¶ 4, 58 Fed. Reg. at 57,645,
111. Although the GATT agreement is a treaty under U.S. law, and the United States is bound by its terms to adopt international standards when possible, it would seem that this very general and hortatory goal is insufficient to bring ICH activities within the class of activities that are conducted "pursuant to treaty." Similarly, the context of the use of the term "international standardization agreement" impliedly contemplates formal public international agreements that have specified goals, rather than the private/governmental mix of participants in ICH. The Draft Statement also provides that "[t]he principal standards organizations that are not connected with a treaty are the International Organization for Standards (ISO) and the International Electrotechnical Commission (IEC)." See 60 Fed. Reg. at 53,080. From the context of this statement it seems clear that FDA does not consider ICH to be an international standardization agreement.
112. OMB Circular No. A-119, 58 Fed, Reg. at 57,645.
113. 60 Fed. Reg. at 53,078.
114. Id. at 53,084.
115. 58 Fed. Reg. at 57,647 (letter from Anne K. Bingaman, Ass't Attorney Gen., Antitust Div., Dep't of Justice, to Allan V. Barman, Adm'r, Off. of Fed. Procurement Policy, Exec. Off. of the President, Off. of Management and Budget (July 27, 1993)) (emphasis added).
116. 60 Fed. Reg. at 53,080.
117. Id. (emphasis added) (citing 21 C.F.R. § 10.95).
118. The Notice on the Policy on Standards includes a discussion of the ICH under the heading "Standards Programs and Practices Within FDA." See id.
119. This policy of openness or "transparency" in rulemaking is reflected throughout the U.S. statutes governing various rulemaking procedures. Thus, for example, the Negotiated Rulemaking Act requires transparency and balanced representation of views of affected parties in negotiated rulemaking activities. Pub. L. No. 101-648, 104 Stat 4969 (1990) (codified at 5 U.S.C. §§ 581-590). See also discussion infra Part IV.E. The Government in the Sunshine Act mandates that all meetings of any agency headed by a collegial body generally must be publicized and open to all interested parties. Pub. L. No. 94-409, 90 Stat. 1241 (1976) (codified at 5 U.S.C § 552(b)). Because FDA has a single chief administrator (the Commissioner) and is therefore not headed by a collegial body, it is not subject to the Government in the Sunshine Act. Nevertheless, the Act demonstrates a strong preference for complete openness and balanced representation in rulemaking by administrative agencies. See also infra Part IV.D (discussion of FACA's openness requirement).
120. This section represents a portion of FDA's governing regulations. 21 C.F.R. § 10.95.
121. See supra notes 37, 47, and accompanying text.
122. 21 C.F.R. § 10.95(b).
123. Id. § 10.95(c).
124. Id. § 10.95(d).
125. See supra note 46.
126. 21 C.F.R. § 10,95(d). ICH, however, is not wholly a private organization, being founded by three governmental regulatory bodies in association with private trade associations representing the industries regulated by those bodies. Section 10.95(d) appears to be directed at an organization that is wholly private, because it mandates that the organization request FDA participation in writing, describing the scope of its activities. See id. § 10.95(d)(1). These requirements are superfluous in an organization in which FDA is a founding member.
127. Id. § 10.95(d)(1)(i-iii).
128. Id. § 10.95(d)(5).
129. Id. § 10.95(d)(5)(ii).
130. The second ICH Term of Reference states that one objective of ICH is to achieve a "more economical" use of human, animal, and material resources. Remarks by executives of the pharmaceutical industry also make it clear that one goal of participating in ICH is to lower the costs of drug development. See, e.g., Second ICH Proceedings, supra note 4, at 17 (opening remarks by William C. Steere Jr., Chairman & CEO, Pfizer Inc.).
131. It seems naive, however, to assume that any savings realized by the pharmaceutical industry will be passed along to consumers. Elementary marketing principles dictate that the selling price of any good is dictated by the value of the good to the purchaser, and bears no relation to the actual cost of producing the good. The exception to this general statement is when the good is an interchangeable commodity that is available from many alternative suppliers. New pharmaceuticals, which inevitably enjoy strong patent protection, are the antithesis of commodity products. Accordingly, pharmaceutical companies would be expected simply to retain any savings realized by regulatory harmonization.
132. 21 C.E.R. § 10.95(5)(iii) (emphasis added).
133. The registration fee for attending the third ICH in Yokohama was 140,000 Japanese yen (about 1330 American dollars). See, Third ICH, Preliminary Program and Registration Forms (1995) (copies on file with author).
134. Id.
135. Id.
136. The ICH Harmonization Process, Closing Report at the third ICH (Dec. 1, 1995) (transcript available from ICH Secretariat).
137. LEWIS CARROLL, ALICE'S ADVENTURES IN WONDERLAND 93-94 (Heritage Press 1941).
138. Pub. L. No. 75-717, §§ 701(a), (e), 52 Stat. 1040 (1938), as amended 21 U.S.C. §§ 371(a), (e) (1994).
139. Pub. L. No. 79-404, 60 Stat. 237 (1946) (codified at 5 U.S.C. §§ 551-559).
140. For a complete discussion of the rulemaking process under section 701(e), and proposals for reform of the process, see Robert W. Hamilton, Rulemaking on a Record by the Food and Drug Administration, 50 TEX. L. REV. 132 (1972).
141. National Nutritional Foods v. Kennedy, 572 F.2d 377, 384 (2d Cir. 1977).
142. Id. at 386.
143. Id.
144. The section 701(e) rulemaking procedure for FDA's proposed rule on the question of whether peanut butter should contain 87% or 90% peanuts took nine years and produced a transcript of 7,736 pages. It has been observed that "the peanut butter proceeding was a great educator of the American legal profession." See 1 KENNETH CULP DAVIS, ADMINISTRATIVE LAW TREATISE § 6.8 (1978). FDA's preference for informal rulemaking is shared by other administrative agencies. See ADMINISTRATIVE CONFERENCE OF THE UNITED STATES: FEDERAL ADMINISTRATIVE PROCEDURE SOURCEBOOK 4-5 (1992) [hereinafter Acus SOURCEBOOK] ("formal rulemaking is used infrequently").
145. The typical period for receipt of written comments is one month from the date of publication of the proposed rulemaking in the Federal Register. This complies with the mandated minimum notice period of 30 days, required under section 553(d) of the APA. See 5 U.S.C. § 553(d).
146. Id. § 706(2)(A). For an analysis of judicial review of administrative rules, see James V. DeLong, New Wine For A New Bottle: Judicial Review in the Regulatory State, 12 VA. L. REV. 399 (1986).
147. 21 C.F.R. § 10.90(a).
148. Title 21 of the Code of Federal Regulations, section 10.80 details the procedures necessary for dissemination of draft regulations. Drafts of proposed notices or regulations may be discussed with, or furnished to, interested persons outside the executive branch only if the drafts are made available to all persons by way of publication in the Federal Register. Id. § 10.80(b)(1), (2).
149. Id. § 10.90(b)(1).
150. Id.
151. Id.
152. Id. § 10.90(b)(2).
153. 5 U.S.C § 553(b)(A).
154. See, e.g., General Motors Corp. v. Ruckelshaus, 742 F.2d 1561 (D.C. Cir.), cert. denied, 471 U.S. 1074 (1984).
155. Southeastern Minerals, Inc. v. Harris, 622 F.2d 758, 766 n.14 (5th Cir. 1980).
156. See, e.g., 60 Fed. Reg. at 11,278. The statements go even further, asserting that a Guideline does not "create or confer any rights, privileges, or benefits for or on any person, nor does it operate to bind FDA in any way." Id. This last statement shows that FDA does not consider the Guidelines to be binding regulations that must be issued using the procedures of title 21 of the Code of Federal Regulations, section 10.80.
157. Id.
158. If a particular characteristic of a product meets the standard found in a guideline issued under section 10.90, FDA is bound to find acceptable at least that aspect of the product's properties. By stating that ICH Guidelines are not issued under section 10.90, FDA is stating impliedly that, even if the characteristic meets the ICH Guideline criteria, the agency retains the right to decline to find that characteristic acceptable. Given FDA's huge investment in ICH in terms of manpower, agency prestige, and scientific credibility, it seems extremely unlikely that the agency will apply a higher standard than required by the ICH Guidelines. In other words, the failure to issue the Guidelines under section 10.90 does not much matter in a practical sense, because the Guidelines will be the de facto acceptable standard.
159. See supra note 89 and accompanying text.
160. A nonlegislative rule still must be published in the Federal Register. See 5 U.S.C §§ 552(a)(1)(D), 553(b), (c).
161. Robert A. Anthony, Interpretive Rules, Policy Statements, Guidances, Manuals, and the Like - Should Federal Agencies Use Them to Bind the Public?, 41 DUKE L.J. 1311, 1321 (1992).
162. See id. See also Michael Asimow, Nonlegislative Rulemaking and Regulatory Reform, 1985 DUKE L.J. 381.
163. See id. See also Michael Asimow, Nonlegislative Rulemaking and Regulatory Reform, 1985 DUKE L.J. 381.
164. Anthony, supra note 96, at 1323.
165. The seemingly circular logic required for deciding the legislative status of an administrative rule confirms Justice Scalia's maxim that "[a]dministrative law is not for sissies." See Antonin Scalia, Judicial Deference to Administrative Interpretations of Law, 1989 DUKE L.J. 511, 511.
166. "A policy statement is an agency statement of substantive law or policy, of general or particular applicability and future effect, that was not issued legislatively and is not an interpretive rule," Anthony, supra note 96, at 1325. Policy statements create new policy that is not legally binding because it was not issued legislatively. Id.
167. Id. at 1328.
168. Id. at 1328-29.
169. It is noteworthy that at least one of the Guidelines has stated that "[s]ponsors submitting future applications may be asked to explain any differences from the approach suggested in the guideline." See 59 Fed. Reg. 48,754.
170. Anthony, supra note 96, at 1329-30.
171. Id.
172. Id.
173. See, e.g., Draft Guideline on Detection of Toxicity to Reproduction for Medicinal Products, 58 Fed. Reg. 21,074 (Apr. 16, 1993) (four-week comment period); 59 Fed. Reg. at 48,734 (twelve-week comment period).
174. See, e.g., 59 Fed. Reg. at 55, 972
175. Patti Goldman, The Democratization of the Development of United States Trade Policy, 27 CORNELL INT'L L.J. 631, 681 (1994).
176. Id. at 645.
177. Blair P. Bremberg, Pre-Rulemaking Regulatory Development Activities and Sources as Variables in the Rulemaking Fairness Calculus: Taking a Soft Look at the Ex-APA Side of Environmental Policy Rulemaking, 6 MINN. L. & POL'Y J, 1 (1991); Ann Bray, Scientific Decision Making: A Barrier to Citizen Participation in Environmental Agency Decision Making, 17 WM. MITCHELL L. REV. 1111 (1991).
178. Blair P. Bremberg, Pre-Rulemaking Regulatory Development Activities and Sources as Variables in the Rulemaking Fairness Calculus: Taking a Soft Look at the Ex-APA Side of Environmental Policy Rulemaking, 6 MINN. L. & POL'Y J, 1 (1991); Ann Bray, Scientific Decision Making: A Barrier to Citizen Participation in Environmental Agency Decision Making, 17 WM. MITCHELL L. REV. 1111 (1991).
179. Generics Firms Oppose ICH Standards, MARKETLETTER, Feb. 20, 1995 (available on IAC Newsletter Database, LEXIS). The trade association representing U.S. generic drug manufacturers expressed concern that adoption of the ICH process would compel more extensive testing of generic drugs than the simple demonstration of bioequivalence that is currently required.
180. Anthony, supra note 96, at 1327. For another analysis of the legislative/nonlegislative rule dichotomy, see Asimow, supra note 97, at 384.
181. Anthony, supra note 96, at 1327. For another analysis of the legislative/nonlegislative rule dichotomy, see Asimow, supra note 97, at 384.
182. Although FDA provides notice of the Guidelines and allows a nominal comment period, the Guidelines conspicuously fail to meet the requirement in section 553 of the APA that proposed rules must reference the legal authority under which they are proposed. 5 U.S.C. § 553(b)(2).
183. See supra note 54.
184. There is precedent for expanding participation in this manner. When Public Citizen, a consumer interest group, demanded access to the Codex Alimentarius process, a meeting between consumer and environmental organizations and FDA was held. Moreover, FDA, the U.S. Department of Agriculture, and the Environmental Protection Agency convened a public forum on the Codex. See Goldman, supra note 109, at 680. As a result of these efforts, interested parties can obtain notices of Codex and U.S. advisory meetings, background material, and draft U.S. positions, and may attend the U.S. advisory meetings to discuss the U.S. position. Parties also may request to attend Codex meetings. Id. Despite this progress, the Codex process still lacks meaningful public participation. See infra notes 13945 and accompanying text.
185. 5 U.S.C. App. § 3.
186. Id. § 10(a)(1).
187. Id. § 10(a)(3).
188. Id. §§ 10(b), (c).
189. Id. § 5(b), (c).
190. 21 C.F.R. § 14.
191. One commentator has observed that FACA is "a little known Act," and that the existence of advisory committees as a branch of government is "practically unknown." Mary Kathryn Palladino, Ensuring Coverage, Balance, Openness and Ethical Conduct for Advisory Committee Members Under The Federal Advisory Committee Act, 5 ADMIN. L.J. 231 (1991).
192. ADMINISTRATIVE CONFERENCE OF THE UNITED STATES, FEDERAL ADMINISTRATIVE SOURCEBOOK, STATUTES AND RELATED MATERIALS 572 (1992).
193. 491 U.S. 438 (1989).
194. Id. at 463. See, however, Food Chem. News v. Young, 900 F.2d 328, 332, cert. denied, 498 U.S. 486 (1990), where the court appeared to further narrow the formulation in Public Citizen. "In the Court's delineation, as we understand it, 'established' indicates 'a Government-formed advisory committee,' . . . , while 'utilized' encompasses a group organized by a nongovernmental entity but nonetheless so 'closely tied' to an agency as to be amenable to 'strict management by agency officials.'" Id. at 333.
195. Public Citizen, 491 U.S. at 459-62.
196. Id. at 456.
197. See, e.g., Washington Legal Found, v. U.S. Sentencing Comm'n, 17 F.3d 1446 (D.C. Cir. 1993); Grigsby Bradford & Co., Inc. v. United States, 869 F. Supp. 984 (D.D.C 1994); Natural Resources Defense Council, Inc. v. Herrington, 637 F. Supp. 116 (D.D.C. 1986), But see, e,g., Alabama-Tomigbee Rivers v. Dep't of Interior, 26 F.3d 1103 (11th Cir. 1994); Northwest Forest Resource Council v. Espy, 846 F. Supp. 1009 (D.D.C 1994); Animal Legal Defense Fund, Inc. v. Shalala, 104 F.3d 424 (D.C. Cir. 1997).
198. 61 F.3d 929 (D.C. Cir. 1995).
199. Id. at 934.
200. Id. at 935-37.
201. 21 C.F.R. § 14.1(6) (emphasis in the original).
202. Public Citizen, 491 U.S. at 462.
203. For example, the D.C. Circuit court has noted that: FACA requires that committees file charters, notify the public in advance of meetings, open the doors to those meetings to all comers, keep detailed minutes, and perhaps most onerous, make documents available for public inspection subject to Freedom of Information Act limitations. 5 U.S-C. App. §§ 9(c), 10(a)-(c). Animal Legal Defense Fund, 104 F.3d at 427.
204. See, e.g., 59 Fed. Reg. 39,398. FDA also might point to the use of the term "information" and cite to its own regulations providing that "[a] committee is not utilized by FDA if it provides only information, as contrasted with advice, or opinions, or recommendations," See 21 C.F.R. § 14.1(6)(ii).
205. Sofamor, 61 F.2d at 937-38. The court noted that the statute that mandated establishment of the panel also established an advisory council for the express purpose of providing advice and recommendation to the Agency for Health Care Policy and Research. Id. at 937. Thus, the conclusion that Congress mandated the purpose of the panel as providing information only to medical practitioners was buttressed by the fact that it also provided a separate means for advising the Research Council.
206. Sofamor, 61 F.2d at 937-38. The court noted that the statute that mandated establishment of the panel also established an advisory council for the express purpose of providing advice and recommendation to the Agency for Health Care Policy and Research. Id. at 937. Thus, the conclusion that Congress mandated the purpose of the panel as providing information only to medical practitioners was buttressed by the fact that it also provided a separate means for advising the Research Council.
207. Goldman, supra note 109, at 682. See also Tom Hilliard, Trade Advisory Committees: Privileged Access for Polluters, Report by Public Citizen's Congress Watch (1991) (report available from Public Citizen).
208. Goldman, supra note 109, at 682. See also Tom Hilliard, Trade Advisory Committees: Privileged Access for Polluters, Report by Public Citizen's Congress Watch (1991) (report available from Public Citizen).
209. Goldman, supra note 109, at 682.
210. Id. at 681.
211. Id.
212. Id.
213. Letter from Patti Goldman, Public Citizen Litigation Group, to Clayton Yeutter, Sec'y of Agriculture, and David Kessler, Comm'r of Food and Drugs, FDA, in Hilliard, supra note 138, at 44.
214. Id.
215. Goldman, supra note 109, at 644.
216. See 59 Fed. Reg. at 8648.
217. There appears to be a split among the circuits as to what is the appropriate relief when FACA has been violated. The D.C. Circuit concluded that "no court has held that a violation of FACA would invalidate a regulation adopted under otherwise appropriate procedures." National Nutritional Foods Ass'n v. Califano, 603 F.2d 327, 336 (D.C. Cir. 1979). The Eleventh Circuit, however, concluded that "to allow the government to use the product of a tainted procedure would circumvent the very policy that serves as the foundation of the Act." Alabama-Tomigbee Rivers, 26 F.3d at 1107.
218. Contrera, supra note 11, at 937.
219. Pub. L. No. 101-648, 104 Stat. 4969 (codified at 5 U.S.C. §§ 561-70). See ADMINISTRATIVE CONFERENCE OF THE UNITED STATES, NEGOTIATED RULEMAKING SOURCEBOOK 2 (1990) (citing regulations governing use of negotiated rulemaking procedures).
220. See generally, ACUS SOURCEBOOK, supra note 79, at 792. See also Phillip J. Harter, The Political Legitimacy and Judicial Review of Consensual Rules, 32 AM, U.L. REV. 471 (1983); Henry H. Perritt, Jr., Negotiated Rulemaking Before Federal Agencies: Evaluation of Recommendations by the Administrative Conference of the United States, 74 GEO. L.J. 1625 (1986).
221. See generally, ACUS SOURCEBOOK, supra note 79, at 792. See also Phillip J. Harter, The Political Legitimacy and Judicial Review of Consensual Rules, 32 AM, U.L. REV. 471 (1983); Henry H. Perritt, Jr., Negotiated Rulemaking Before Federal Agencies: Evaluation of Recommendations by the Administrative Conference of the United States, 74 GEO. L.J. 1625 (1986).
222. See generally, ACUS SOURCEBOOK, supra note 79, at 792. See also Phillip J. Harter, The Political Legitimacy and Judicial Review of Consensual Rules, 32 AM, U.L. REV. 471 (1983); Henry H. Perritt, Jr., Negotiated Rulemaking Before Federal Agencies: Evaluation of Recommendations by the Administrative Conference of the United States, 74 GEO. L.J. 1625 (1986).
223. Pub. L. No. 101-648, § 5, 104 Star. at 4976. The Act was due to be repealed on November 29, 1996. The sunset provision, however, was itself repealed by Pub. L. No. 104-320, § 11(a), 110 Stat. 3873 (1996).
224. ACUS SOURCEBOOK, supra note 79, at 794. Prior to enactment of the Negotiated Rulemaking Act, the use of negotiated rulemaking had been approved sub silentio by the courts. See Safe Bldgs. Alliance v. EPA, 846 F.2d 79 (D.C. Cir. 1988); Natural Resources Defense Council v. EPA, 907 F.2d 1146 (D.C. Cir 1990).
225. The Negotiated Rulemaking Act requires, inter alia, that an agency contemplating establishing a negotiation committee must publish a notice in the Federal Register identifying the interests likely "to be significantly affected" by the proposed rule, listing proposed persons to represent those interests, and explaining how a person can apply for or nominate another person for membership of the committee. 5 U.S.C §§ 584(a)(3), (4), (8). Before a committee may be established the agency must then determine, after receiving comments from the published notice, that the committee can "adequately represent the interests that will be significantly affected" by the proposed rulemaking. Id. § 585(a)(1).
226. Contrera, supra note 11, at 938.
227. See Generic Firms Oppose ICH Standards, supra note 112.