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

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ISBN-13: 

9781420073546


ISBN: 

1420073540


Edition:  2
Pub Date: 
Publisher:  CRC Press
Summary: 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 Editionfocuses 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 resourc...es. 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:

Pisano, Douglas J. is the author of FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, published 2008 under ISBN 9781420073546 and 1420073540. One hundred fifty four FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics textbooks are available for sale on ValoreBooks.com, five used from the cheapest price of $205.80, or buy new starting at $180.84.
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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

ISBN-13: 9781420073546


ISBN: 1420073540


Edition: 2nd


Pub Date:
Publisher: CRC Press
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