This presentation will cover the contents of the guidance that was given. FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP.
GMP for Phase 1 Products - Webinar By GlobalCompliancePanel
7 August 2012, Wilmington, United States
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Online Training, 1000 N West Street, DE, Suite 1200, Wilmington, 19801, United States
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