Knowledge Brief: Overview, Regulatory Framework, US FDA

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By Dr. Kate McCormick
Level: Fundamental

This Knowledge Brief provides a basic overview of the US FDA's organizational structure and licensing procedures relevant to pharmaceutical manufacturing and regulation.

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Knowledge Briefs are developed from a wide variety of resources including ISPE training courses, conferences, seminars, technical documents, individual authors who are subject matter experts, as well as expert interchanges within the Society's Communities of Practice.