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

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

This book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System ...

By David Mantus
File Size: 6977 KB
Print Length: 360 pages
Publication Date: April 16, 2007
Sold by: Amazon Digital Services LLC
Language: English
ASIN: B000PMG8SQ
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Format: PDF Text TXT book

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Reviews:
Mostly this book covers (perhaps adequately) FDA regulation of the development and approval process of new drugs. These new drugs are (by and large) developed by huge drug companies who doubtless employ teams of lawyers in connection with their FDA submissions and regulatory compliance, and it is qu...


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