An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Second Edition is fully updated to reflect recent advances in science and technology and new laws and regulations. Breakthroughs in cellular and gene therapy, immunotherapy, precision medicine, and digital health are changing the face of healthcare and regulation. The updates brought about by the 21st Century Cures Act and subsequent PDUFA Reauthorizations, as well as signing into law the “Modernization of Cosmetic Regulation Act of 2022,” which will transform FDA’s oversight of cosmetics, are fully reflected in all chapters of the book.

This book provides graduate students and industry professionals with comprehensive information on approval processes with the FDA and other country regulation organizations. Regulatory science professionals working with not only drugs, but biologics, medical devices, food and additives, cosmetics, veterinary products, and tobacco will benefit from this comprehensive overview of the regulatory environment.

• Provides an in-depth overview on how drugs, cosmetics, food, and tobacco products are regulated by the FDA and agencies around the world
• Includes chapters that have been fully revised and updated
• Covers the regulatory changes brought up by the 21st Century Cures Act and subsequent PDUFA Reauthorizations
• Presents a new chapter on how to ensure medical product safety