Science and regulatory rituals associated with the drug development process

Food and Drug Law Journal

Volumn 52, Issue 2, 1997, Pages 155-161

  Versteegh, Larry R ^a  

^a PROCTER AND GAMBLE PHARMACEUTICALS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

CLINICAL TRIAL; CONFERENCE PAPER; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; LAW; LD 50; SCIENCE;

CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; HUMANS; SCIENCE; TIME FACTORS; TOXICITY TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030965818     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (10)

1. Pub. L. No. 102-571, 106 Stat. 4491 (codified in scattered sections of 21 U.S.C, (1994)).
2. Personal communication with Dr. Carl C. Peck, Dir., Center for Drug Development Science, Georgetown University, This information also was presented generally by Dr. Peck in his introductory remarks at the seminar, "Drug Development: Who Knows Where the Tune Goes?" Washington, D.C. (June 17, 1996).
3. See E. I. Goldenthal, Current Views on Safety Evaluation of Drugs, FDA PAPERS, May 1968, at 13-19.
4. See id.
5. See generally J. Weissinger, 26 DRUG INFO. J. 133 (1992).
6. 50 Fed. Reg. 7452 (Feb. 22, 1985).
7. 52 Fed. Reg. 8798 (Mar. 19, 1987).
8. 53 Fed. Reg. 39,650 (Oct. 11, 1988).
9. FOOD AND DRUG ADMIN., CONTENT AND FORMAT OF INVESTIGATIONAL NEW DRUG APPLICATIONS (INDs) FOR PHASE I STUDIES OFDRUGS, INCLUDING WELL-CHARACTERIZED, THERAPEUTIC, BIOTECHNOLOGY-DERIVED PRODUCTS, FDA GUIDANCE FOR INDUSTRY (1995).
10. Pub. L No. 104-134, 110 Stat. 1321 (codified at 21 U.S.C. §§ 381, 382; 42 U.S.C. § 262).