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FDA Regulatory Affairs

A Guide for Prescription Drugs, Medical Devices, and Biologics

Language EnglishEnglish
E-book Adobe ePub DRM
Publishers CRC Press, August 2008
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations... Full description
? points 580 b
236.79 VAT included
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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

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About the book

Full name FDA Regulatory Affairs
Language English
Binding E-book - Adobe ePub DRM
Date of issue 2008
Number of pages 464
EAN 9781040061978
Libristo code 47331861
Publishers CRC Press
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