Biologics Development : A Regulatory Overview.cMark Mathieu
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Author: Mark Mathieu
Number of Pages: 283 pages
Published Date: 30 Jan 2004
Publisher: Parexel International Corporation
Publication Country: United States
Language: English
Format: eBook
ISBN: 9781882615674
File size: 20 Mb
Download Link: Biologics Development A Regulatory Overview
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This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.
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