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(Ebook) FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics by Douglas J. Pisano, David Mantus ISBN 9781587160073, 1587160072

  • SKU: EBN-1126828
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Instant download (eBook) FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics after payment.
Authors:Douglas J. Pisano, David Mantus
Pages:466 pages.
Year:2003
Editon:1
Publisher:Informa Healthcare
Language:english
File Size:7.55 MB
Format:pdf
ISBNS:9781587160073, 1587160072
Categories: Ebooks

Product desciption

(Ebook) FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics by Douglas J. Pisano, David Mantus ISBN 9781587160073, 1587160072

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
*Free conversion of into popular formats such as PDF, DOCX, DOC, AZW, EPUB, and MOBI after payment.

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