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Search - FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition
FDA Regulatory Affairs A Guide for Prescription Drugs Medical Devices and Biologics Second Edition
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation require...  more »
ISBN-13: 9781420073546
ISBN-10: 1420073540
Publication Date: 8/11/2008
Pages: 464
Edition: 2
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Publisher: Informa HealthCare
Book Type: Hardcover
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