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FDA Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices, and Biologics, PDF eBook

FDA Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices, and Biologics PDF

Edited by Douglas J. Pisano, David S. (Cubist Pharmaceuticals, Lexington, Massachusetts, USA) Mantus

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Please note: eBooks can only be purchased with a UK issued credit card and all our eBooks (ePub and PDF) are DRM protected.

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.

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