An Overview of FDA Regulated Products

An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Second Edition is a complete reference and learning resource for those working in the regulatory affairs or aspiring to join the industry. This book is fully updated to reflect recent advances in science and technology as well as new laws and regulations that have been implemented in recent years. Breakthroughs in cellular and gene therapy, immunotherapy, precision medicine, and digital health are constantly changing the face of healthcare and how these products are regulated. The updates brought about by the enactment of the 21st Century Cures Act and subsequent PDUFA Reauthorizations, as well as the 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. An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Second Edition provides graduate students and industry professionals with the key understanding of 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 the comprehensive overview of the regulatory environment established to approve these products.

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