A review of the safety of generic drugs

Transplantation Proceedings

Volumn 31, Issue 3 SUPPL. 1, 1999, Pages 23S-24S

  Dighe, S V ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG;

BIOEQUIVALENCE; CONFERENCE PAPER; DRUG COST; DRUG EFFICACY; DRUG FORMULATION; DRUG LABELING; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL;

EID: 0032938160     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0041-1345(99)00109-8     Document Type: Conference Paper

References (5)

1. Drug Price Competition and Patent Term Restoration Act of 1984. Public Law 98-417, 98 Stat. 1585-1605, September 1984.
2. Dighe S.V., Adams W.P. Pharmaceutical Bioequivalence. 1991;356 Marcel Dekker Inc, New York.
3. Code of Federal Regulations, 21, Food and Drugs, Part 314.94, Content and format of an abbreviated application, pp. 134, April 1995.
4. Code of Federal Regulations, 21, Food and Drugs, Part 314.80, Postmarketing reporting of adverse drug experiences, pp. 126, April 1995.
5. Ackerman SJ: An FDA CONSUMER Special Report. January 1988, p 51.