FDA Regulatory Affairs —— A Guide for Prescription Drugs, Medical Devices, and Biologics

----- FDA规章事务：处方药、医疗设备与生物制品指南

ISBN: 9781420073546 出版年：2008 页码：466 CRC Press

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in