Describes the U.S. FDA with particular emphasis on their role in the development of new drugs, biological products, medical devices and today. Provides context for the process of drug approval by the FDA history and description of the organizational structure.

Describes the U.S. FDA with particular emphasis on their role in the development of new drugs, biological products, medical devices and today. Provides context for the process of drug approval by the FDA history and description of the organizational structure.
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Robert F. Higgins,
Richard G. Hamermesh,
Virginia A. Fuller
23 pages.
Release Date: 24, January 2007. Prod #: 807050-PDF-ENG
U.S. Food and Drug Administration HBR case solution