Transplantation Proceedings
Volume 31, Issue 3, Supplement 1 , Pages 23S-24S , May 1999

A review of the safety of generic drugs

  • S.V Dighe

      Affiliations

    • Corresponding Author InformationAddress reprint requests to Shrikant V. Dighe, PhD, 9811 Wildwood Road, Bethesda, MD 20814

References 

  1. Drug Price Competition and Patent Term Restoration Act of 1984. Public Law 98–417, 98 Stat. 1585–1605, September 1984
  2. Dighe SV, Adams WP. In: Pharmaceutical Bioequivalence. New York: Marcel Dekker Inc; 1991;p. 356
  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

PII: S0041-1345(99)00109-8

Transplantation Proceedings
Volume 31, Issue 3, Supplement 1 , Pages 23S-24S , May 1999

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