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, 2004

About this Item

The book is complete and readable, with all pages and cover intact. Dust jacket, shrink wrap, or boxed set case may be missing. Pages may have light notes, highlighting, or minor water exposure, but nothing that affects readability. May be an ex-library copy and could include library markings or stickers.

Seller Inventory # BSM.OYBZ

Bibliographic Details

• Title: Biologics Development: A Regulatory Overview
• Publisher: Barnett Educational Services / Chi
• Publication Date: 2004
• Language: English
• ISBN 10: 1882615670
• ISBN 13: 9781882615674
• Binding: Hardcover
• Edition: 3rd Edition
• Condition: acceptable

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.