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

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  • ISBN-13: 9781420073546
  • ISBN: 1420073540
  • Edition: 2
  • Publication Date: 2008
  • Publisher: CRC Press


Pisano, Douglas J., Mantus, David S.


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 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: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 ISBN 1420073540.

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