An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, 2nd Edition

An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Second Edition, edited by Eunjoo Pacifici and Susan Bain, offers a fully updated guide to the regulatory landscape for FDA-regulated products. Covering drugs, biologics, medical devices, cosmetics, food, tobacco, and veterinary products, this book bridges the gap between scientific innovation and regulatory compliance. It reflects recent advances in science, technology, and legislation—including the 21st Century Cures Act and the Modernization of Cosmetic Regulation Act of 2022—making it an essential resource for graduate students, industry professionals, and regulatory science specialists.

Key Features:

• Comprehensive overview of FDA regulatory processes across drugs, biologics, medical devices, cosmetics, food, and tobacco.
• Fully updated chapters reflecting recent scientific advances and regulatory changes.
• Coverage of legislative updates, including the 21st Century Cures Act and PDUFA Reauthorizations.
• New chapter on ensuring medical product safety.
• Useful for graduate students, industry professionals, and regulatory science specialists worldwide.
• Integrates global regulatory perspectives alongside FDA-specific guidelines.

Product Details

• Publisher ‏ : ‎ Elsevier
• Publication date ‏ : ‎ June 13, 2025
• Language ‏ : ‎ English
• ISBN-10 ‏ : ‎ 0128111550
• ISBN-13 ‏ : ‎  978-0128111550