FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (2008)

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and BiologicsPublisher: Informa HealthCare English ISBN: 1420073540 464 pages 2008 PDF 6 MbDescription: 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 with respect to compliance and product approval.

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