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OverviewThis 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. Full Product DetailsAuthor: Mark MathieuPublisher: Parexel Publishing Imprint: Parexel Publishing Edition: 3rd ed. Dimensions: Width: 21.10cm , Height: 2.30cm , Length: 27.40cm Weight: 0.998kg ISBN: 9781882615674ISBN 10: 1882615670 Pages: 283 Publication Date: 01 January 2004 Audience: General/trade , General Format: Hardback Publisher's Status: Active Availability: In stock  We have confirmation that this item is in stock with the supplier. It will be ordered in for you and dispatched immediately. Table of ContentsReviewsAuthor InformationTab Content 6Author Website:Countries AvailableAll regions |
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