US Drug Safety Regulation History and Monitoring System

Author: Cao Liya
Publisher:
Publish Date: 2006-03-01
Features: The U.S. Food and Drug Administration (FDA) is the world-renowned authoritative institution for food and drug regulation, and the scientific standards it establishes have become models for countries worldwide to emulate. The first part of this book introduces the history of U.S. drug regulation in chronological order, with numerous detailed cases reflecting the political and economic contexts related to drug regulation, helping readers gain a comprehensive and vivid understanding of the FDA's journey. The second part comprehensively covers the FDA's drug safety monitoring system, including the agencies involved, procedures, methods, as well as the collection, evaluation, and utilization of case reports. The appendix provides additional information on some of the FDA's organizational structures and commonly used forms and documents. This book aims to inspire readers to find solutions to China's drug safety regulatory challenges through research on the FDA.