An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Second Edition is your essential guide, fully revised and updated to reflect the latest breakthroughs in science, technology, and regulatory practices. Significant advancements in cellular and gene therapy, immunotherapy, precision medicine, and digital health are reshaping healthcare and its oversight. This edition incorporates the impactful changes brought by the 21st Century Cures Act, subsequent PDUFA Reauthorizations, and the new “Modernization of Cosmetic Regulation Act of 2022,” which revolutionizes the FDA’s approach to cosmetics, ensuring all chapters are current.
Designed for graduate students and industry professionals, this book delivers a thorough exploration of the FDA approval processes, as well as insights into regulations from other global authorities. Regulatory science professionals engaged in pharmaceuticals, biologics, medical devices, food additives, cosmetics, veterinary products, and tobacco will find this overview invaluable for navigating the intricate regulatory landscape.
Highlights include:
– A comprehensive analysis of how the FDA and global agencies regulate drugs, cosmetics, food, and tobacco products.
– Fully revised and updated chapters for the most accurate information.
– In-depth discussion on regulatory changes from the 21st Century Cures Act and PDUFA Reauthorizations.
– A new chapter dedicated to ensuring the safety of medical products.
Get ready to enhance your understanding of FDA regulations and stay ahead in your field!
