An overview of how the food and drug administration regulates new drug development in the United States

Drug Information Journal

Volumn 30, Issue 3, 1996, Pages 745-751

  Stringer, Stan ^a  

^a AAC Consulting Group   (United States)

Author keywords

Food and Drug Administration; Investigational new drug; New drug application; New drug development

Indexed keywords

NEW DRUG;

CLINICAL STUDY; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG STORAGE; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; REVIEW; UNITED STATES;

EID: 0029841296     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000318     Document Type: Review

References (7)

1. PDA. From Test Tube to Patient: New Drug Development in the United States. PDA Consumer Special Report. March 1990. 2.21CFR312.
2. PDA. From Test Tube to Patient: New Drug Development in the United States. PDA Consumer Special Report. 2nd ed. January 1995.
3. PDA. New Drug Evaluation Guidance: Refusal to File. July 12, 1993.
4. 21CFR314.
5. Brown MS, Richard BW. Advisory Committees and the Drug Approval Process. J Clin Res Drug Dev. 1988:2:15-27.
6. Barr D. The Changing Approval Process: Preapproval Inspection. Food Drug Law J. 1992;47: 359-362.
7. 21 CFR 314.80.