The FDA’s New Procedures for the Use of Investigational Drugs in Treatment

JAMA: The Journal of the American Medical Association

Volumn 259, Issue 15, 1988, Pages 2267-2270

  Young, Frank E ^a   Norris, John A ^a   Levitt, Joseph A ^a   Nightingale, Stuart L ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; BOOK; CLINICAL ARTICLE; FOOD AND DRUG ADMINISTRATION; HUMAN;

ACQUIRED IMMUNODEFICIENCY SYNDROME; CATASTROPHIC ILLNESS; CLINICAL PROTOCOLS; CLINICAL TRIALS; DRUG INFORMATION SERVICES; HUMAN; INFORMED CONSENT; ORPHAN DRUG PRODUCTION; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; THYMIDINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; ZIDOVUDINE;

EID: 0023944059     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.1988.03720150043034     Document Type: Article

References (7)

1. Nightingale SL: Treatment use and sale of investigational drugs, FROM THE FOOD AND DRUG ADMINISTRATION. JAMA 1987;257:1858.
2. Investigational new drug, antibiotic, and biological drug product regulations; treatment use and sale; reproposed rule. Federal Register 1987;52 (March 19):8850-8857.
3. Nightingale SL: Final rule on treatment use and sale of investigational drugs, FROM THE FOOD AND DRUG ADMINISTRATION. JAMA 1987;258:179.
4. Investigational new drug, antibiotic, and biological drug product regulations; treatment use and sale; final rule. Federal Register 1987;52(May 22):19466-19477.
5. New drug, antibiotic, and biologic drug product regulations; final rule. Federal Register 1987;52 (March 19):8798-8847.
6. 21CFR parts 50 and 56.
7. 21 CFR §312.32.