FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics / edited by Douglas J. Pisano, David S. Mantus.

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 co...

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Bibliographic Details
Online Access: Full Text (via Taylor & Francis)
Other Authors: Pisano, Douglas J., Mantus, David
Format: eBook
Language:English
Published: New York : Informa Healthcare USA, ©2008.
Edition:2nd ed.
Subjects:
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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 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.
Physical Description:1 online resource (viii, 448 pages) : illustrations.
Bibliography:Includes bibliographical references and index.
ISBN:9781420073553
1420073559