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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics - Pisano, Douglas J (Editor), and Mantus, David S (Editor)
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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 requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates ...

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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics 2008, CRC Press, Oxford

ISBN-13: 9781420073546

2nd edition

Hardcover

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics 2003, CRC Press, Boca Raton, FL

ISBN-13: 9781587160073

Hardcover