Biologics Development: A Regulatory Overview

Mark P. Mathieu; Mark Mathieu; Mathieu, Mark P.

ISBN 10: 1882615670 / ISBN 13: 9781882615674

Published by Barnett Educational Services / Chi (edition 3), 2004

About this Item

It's a well-cared-for item that has seen limited use. The item may show minor signs of wear. All the text is legible, with all pages included. It may have slight markings and/or highlighting.

Seller Inventory # 1882615670-11-1

Bibliographic Details

• Title: Biologics Development: A Regulatory Overview
• Publisher: Barnett Educational Services / Chi (edition 3)
• Publication Date: 2004
• Language: English
• ISBN 10: 1882615670
• ISBN 13: 9781882615674
• Binding: Hardcover
• Edition: 3.
• Condition: Very Good

About this title

Synopsis

Written by industry experts and officials at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), this book provides a comprehensive review of FDA’s emerging processes for regulating and approving biological products. An extensive examination of FDA’s regulation of biologic products, from preclinical testing to postmarketing regulatory requirements and from user fees to electronic submissions is presented. It also evaluates the consolidation and transfer of specific biologic product reviews from CBER to CDER.