The Food and Drug Administration's use of postmarketing (Phase IV) study requirements: exception to the rule?

Food Drug Law J. 2006;61(2):295-383.
No abstract available

Publication types

  • Historical Article

MeSH terms

  • Anti-HIV Agents
  • Clinical Trials, Phase IV as Topic* / legislation & jurisprudence
  • Dexfenfluramine
  • Drug Approval* / history
  • Drug Approval* / legislation & jurisprudence
  • Drug Approval* / methods
  • History, 20th Century
  • Lactones
  • Product Surveillance, Postmarketing* / trends
  • United States
  • United States Food and Drug Administration

Substances

  • Anti-HIV Agents
  • Lactones
  • Dexfenfluramine