FDA Regulatory Affairs: A Guide for Prescription Drugs Medical Devices and Bio
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Publisher: Informa HealthCare|English | ISBN: 1420073540 | 464 pages | 2008 | PDF | 6 Mb
Description: 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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