FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition   Books Buy Click for detailed information FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition from: Informa HealthCare List Price: $199.95 Bioportfolio's Price: $159.96 You Save: $39.99 (20%) Prices subject to change. This product in another region: UK | USA Availability: Usually ships in 24 hours Click to buy Editorial Review: Product 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. FDA Regulatory Affairs: Related Items: Drugs-From Discovery to Approval Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators see more FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

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