New Third Edition!

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. Biologics Development: A Regulatory Overview provides the most detailed analysis of each stage of the biological product development process available anywhere:

• CDER's emerging organization and processes for regulating and reviewing therapeutic biological products.
• CBER's processes for regulating and reviewing cellular and gene therapies, vaccines, and blood products.
• How CDER and CBER are evolving their procedures and requirements to address new challenges presented by the user-fee program, risk management priorities, and internal agency initiatives.
• Emerging standards for the clinical and nonclinical testing of biological products.

Edited by Mark Mathieu, PAREXEL International Corporation
300 pages, ISBN# 1-882615-67-0. Hardcover.