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Find more info., search and price compare for FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition by Binding: Hardcover, 2 edition, 464 pages Publisher: Informa HealthCare Weight: 1.6 pound Dimension: H: 1.1 x L: 9.1 x W: 6.1 inches ISBN 10: 1420073540 ISBN 13: 9781420073546 Click here to search for this book and compare price at 40+ bookstores with AddALL.com! If you cannot find this book in our new and in print search, be sure to try our used and out of print search too! |
Book 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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