Biologics Development: A Regulatory Overview

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.