An FDA perspective on the drug development process

Food and Drug Law Journal

Volumn 52, Issue 2, 1997, Pages 145-150

  Woodcock, Janet ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

CLINICAL TRIAL; CONCENTRATION RESPONSE; CONFERENCE PAPER; COST; DOSE RESPONSE; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; LAW; STANDARD;

DRUG APPROVAL; EFFICIENCY, ORGANIZATIONAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030908349     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (6)

1. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was initiated in 1990. It is a unique project that brings together the regulatory authorities of Europe, Japan, and the United States, and experts from the pharmaceutical industry in those three regions. These representatives discuss scientific and technical aspects of product registration and administrative functions. The ICH Steering Committee, supported by a small Secretariat, directs and oversees the work. The Steering Committee also is assisted by six ICH Coordinators, who ensure contact and communication between the parties. The ICH Secretariat may be contacted vie E-mail: ich@ifpma.org or by mail: ICH Secretariat c/o IFPMA, 30 rue de St-Jean, P.O. Box 9, 1211 Geneva 18, Switzerland. Tel: +41 (22) 3401200. FAX: +41 (22) 3458275. ICH Coordinators are as follows: In Europe - European Commission-European Union and the European Federation of Pharmaceutical Industries' Association; in Japan - Ministry of Health and Welfare (Japan) and Japan Pharmaceutical Manufacturers Association; in United States - U.S. Food and Drug Administration and the Pharmaceutical Research and Manufacturers of America. ICH Observers act as a link with non-ICH countries and regions. They include: the World Health Organization, the European Free Trade Area (represented at ICH by Switzerland), and Canada (represented at ICH by the Drugs Directorate, Health Canada). Additional information about ICH can be found on the CDER homepage: http://www.fda.gov/cder. See also ICH Guideline, Validation of Analytical Procedures, Part VIII (FDA Dkt. No. 94D-0016) (1995); Final Guideline, 60 Fed. Reg. 11,260 (Mar. 1, 1995).
2. See New Procedures for Original Filings of INDs - Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase I Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. This guidance has been prepared by CDER and the Center for Biologics Evaluation and Research at FDA. It does not create nor confer any specific rights, and does not operate to bind FDA or the industry. The guidance does, however, represent the agency's current thinking on data requirement issues related to the initial entry of an unapproved drug into human studies in the United States.
3. A "clinical hold" is an order, issued by an FDA division director with responsibility for review of the IND, to the sponsor of the drug. It is intended to delay a proposed clinical investigation or to suspend an ongoing investigation. The order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjects may not be given the investigational drug or recruited to the study. Parties already involved in the study should be removed from therapy involving the investigational drug unless specifically permitted by FDA in the interest of patient safety. See 21 C.F.R. § 312.42 (1996); MAPP § 6030.1.
4. If the sponsor disagrees with the reasons cited for clinical hold, the sponsor may request reconsideration of the decision by the Clinical Holds Oversight Committee. FDA is committed to resolving such disputes amicably through the cooperative exchange of information and views. See 21 C.F.R. § 312.48.
5. There has been some ICH standardization of good clinical practice (GCP) mandates on how clinical studies are to be conducted. See ICH E6, Good Clinical Practice (GCP): Consolidated Guideline. An ICH harmonized tripartite guideline on GCP for the conduct of clinical studies was finalized and adopted by the ICH Steering Committee in May 1996. This document sets a tripartite standard, covering the aspects of preparation, monitoring, reporting, and archiving of clinical trials, and incorporating addenda on the Essential Documents and on the Investigator's Brochure, which have been agreed upon previously through the ICH process. See also 62 Fed. Reg. 24,302 (May 2, 1997).
6. E.g., certain products intended to treat HIV infection, including: NORVIR (ritonavir) (72 days total review time); CRIXIVAN (indinavir sulfate) (42 days total NDA review time); EPIVIR (larnivudine) (4.4 months to approval); and INVIRASE (saquinavir) (2.2 months to approval). FOOD AND DRUG ADMIN., ALMANAC 42-43 (1996).