FDA Pre-Approval Inspection

In this course learn about the Food and Drug Administration (FDA)’s Pre-Approval Inspection (PAI). The Food, Drug, and Cosmetic Act provides that FDA may approve an NDA or an ANDA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug are found adequate to ensure and preserve its identity, strength, quality, and purity.

Language: English

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