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Biologics Development: A Regulatory Overview, by Mark P. Mathieu, Mark Mathieu, Mark P. Mathieu
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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.
- Sales Rank: #1401775 in Books
- Brand: Brand: Parexel Intl Corp
- Published on: 2004-01-01
- Original language: English
- Number of items: 1
- Dimensions: .90" h x 8.30" w x 10.80" l, 2.20 pounds
- Binding: Hardcover
- 283 pages
- Used Book in Good Condition
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