A self-contained single source complete with pertinent references and practical outlines for policies and procedures, this book covers how to understand and comply with U.S. drug development and manufacturing regulations. It explores the control of drug research and the manufacturing industry, introduces basic industry experience and techniques, and presents tried and true methods for applying the theory to everyday problems. The author discusses the 10 critical administrative enforcement areas, including recall, application integrity, injunction, seizure, and more, then supplements the topics with regulations, lawsuit case studies, enforcement information, and reference material.