Thursday, July 24, 2008

FDA Will Exempt Phase 1 Drugs from GMP Regulations

Good article on FDANews, "FDA Moves Forward With Exempting Phase I Drugs From GMPs." In the article, the agency is cited and says, "FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture.”

Read more about this:

  1. Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials (the FDA final rule)
  2. Guidance for Industry CGMP for Phase 1 Investigational Drugs (FDA guidance)

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