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Biologics Development: A Regulatory Overview 3rd Edition (2004)
Cambridge Healthtech Institute, Jan 2004
This publication, Biologics Development: A Regulatory Overview 3rd Edition (2004)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.
This report 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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