Biologics Development: A Regulatory Overview

  • ISBN-13: 9781882615674
  • Author: Mark P. Mathieu
  • Publisher: Parexel Intl Corp
  • Publication date: 2004-01-01
  • Edition: 3
  • Language: English
  • Pages: 283
  • $57.86
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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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