FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Douglas J. Pisano, David S. Mantus
Taylor & Francis, Aug 11, 2008 - Medical - 464 pages
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.
FDA Regulatory Affairs:
Three all-new chapters cover:
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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and ...
Douglas J. Pisano,David S. Mantus
No preview available - 2008