Biologics Development: A Regulatory Overview

Science & Math

Mark Mathieu

Biological Sciences

Parexel Intl Corp

New drug development: A regulatory overview

Parexel

<p>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.</p>

Mark P. Mathieu

Mathieu, Mark P.

Barnett Educational Services / Chi

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Books by Mark Mathieu