FDA Guidance Regarding the Promotion of Off-Label Uses of Drugs : Legal Issues.

Reviews FDA guidance regarding promotion of off-label drug use. Summarizes relevant provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) and related regulations that have been used to address misbranding violations of FFDCA that relate to pharmaceutical manufacturer promotion of off-label...

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Bibliographic Details
Corporate Authors: Library of Congress. Congressional Research Service, ProQuest (Firm)
Format: eBook
Language:English
Published: [Place of publication not identified] : [publisher not identified], 2009.
Series:U.S. Congressional Research.
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Call Number: CRS-2009-AML-0190
 
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CRS-2009-AML-0190 Available