Presents a comprehensive introduction to the U.S. regulatory environment for healthcare products. Explores the mission, history, and organization of the FDA and other federal agencies that regulate food, drugs, biologics, and devices. Traces the development of major U.S. laws (e.g., the Pure Food and Drug Act of 1906, the Food, Drug, and Cosmetic Act of 1938) and their amendments. Examines the end-to-end product approval process from nonclinical testing and clinical trials through regulatory submissions and postapproval requirements.