Biologics Development: A Regulatory Overview

Biologics Development: A Regulatory Overview
- Used Book in Good Condition
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.
Country USA
Brand Brand: Parexel Intl Corp
Manufacturer Barnett Educational Services / Chi
Binding Hardcover
UnitCount 1
EANs 9781882615674
ReleaseDate 0000-00-00

Country	USA
Brand	Brand: Parexel Intl Corp
Manufacturer	Barnett Educational Services / Chi
Binding	Hardcover
UnitCount	1
EANs	9781882615674
ReleaseDate	0000-00-00

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