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FDA Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs

Origin/Publisher:

FDA

Content:
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials

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