An Overview of FDA Regulated Products
eBook - ePub

An Overview of FDA Regulated Products

From Drugs and Cosmetics to Food and Tobacco

  1. 356 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

An Overview of FDA Regulated Products

From Drugs and Cosmetics to Food and Tobacco

About this book

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

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Information

Publisher
Academic Press
Year
2025
Edition
2
eBook ISBN
9780443237812
Topic
Medicine
Subtopic
Operations

Table of contents

  1. Title of Book
  2. Chapter 1. Introduction to Food and Drug Administration regulated products
  3. Chapter 2. Regulatory agencies of the ICH: authorities, structures, and functions
  4. Chapter 3. Drugs
  5. Chapter 4. Biologics
  6. Chapter 5. Medical device and diagnostic products
  7. Chapter 6. Combination products, borderline products, and companion diagnostics
  8. Chapter 7. Food
  9. Chapter 8. Veterinary products
  10. Chapter 9. Dietary supplements
  11. Chapter 10. Cosmetics
  12. Chapter 11. Tobacco products
  13. Chapter 12. Quality
  14. Chapter 13. Ensuring medical product safety
  15. Index

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Yes, you can access An Overview of FDA Regulated Products by Eunjoo Pacifici,Susan Bain in PDF and/or ePUB format, as well as other popular books in Medicine & Operations. We have over 1.5 million books available in our catalogue for you to explore.