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Elsevier

An Overview of FDA Regulated Products

From Drugs and Cosmetics to Food and Tobacco

  • 2nd Edition - March 26, 2025
  • Latest edition
  • Editors: Eunjoo Pacifici, Susan Bain
  • Language: English

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 l… Read more

Description

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.

Key features

  • 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

Readership

Students enrolled in regulatory science/affairs, biomedical engineering, food science, pharmacy, veterinary science, medicine, and translational science programs, Early career professionals in the regulated industry, Entrepreneurs in life sciences and medical technologies, Analysts in investment firms and venture capital firms, Professionals in law firms and consulting companies with a vested interest in the regulated industry, Journalists

Table of contents

1. Introduction to regulated products

2. Regulatory authorities

3. Drugs

4. Biologics

5. Medical Devices and Diagnostics

6. Combination products, borderline products, and companion diagnostics

7. Foods and food additives

8. Veterinary products

9. Dietary supplements

10. Cosmetics

11. Tobacco products

12. Quality

13. Ensuring Medical Product Safety

Product details

  • Edition: 2
  • Latest edition
  • Published: March 26, 2025
  • Language: English

About the editors

EP

Eunjoo Pacifici

Eunjoo Pacifici received her doctor of pharmacy and PhD in toxicology from the University of Southern California. She conducted her graduate research in the laboratory of Dr. Alex Sevanian in the Institute for Toxicology at USC, where she studied the mechanism of oxidative damage and repair in endothelial cell membrane. After receiving her graduate degrees, Pacifici worked at Amgen and gained experience in conducting clinical research with a special focus on Asia Pacific and Latin America regions. She initially worked in the clinical development group managing U.S. investigational sites and central laboratories and then went on to work in the Asia Pacific/Latin America group interfacing with local clinical and regulatory staff in Japan, People’s Republic of China, Taiwan and Mexico. She represented regional clinical and regulatory views on therapeutic product development teams and led satellite task forces in order to align local efforts with U.S. activities.
Affiliations and expertise
Chair and Associate Professor of Regulatory and Quality Sciences, Los Angeles, CA, USAAssociate Director, D. K. Kim International Center for Regulatory Science, School of Pharmacy, University of Southern California, Los Angeles, CA, USA

SB

Susan Bain

Susan Bain, DRSc, is an assistant professor of Regulatory and Quality Sciences at USC and previously was a professor of practice and program director for clinical, regulatory and quality at Keck Graduate Institute (KGI) and adjunct professor of practice and concentration coordinator for clinical and regulatory in KGI’s School of Pharmacy. Dr. Bain is an accomplished quality and regulatory professional with experience in the medical device, pharmaceutical and biotechnology industries. She has a diverse regulatory compliance background in a broad range of FDA-regulated industries. She received a doctorate of regulatory science, a master of science in regulatory science from USC and a bachelor of science in biological science from Cal Poly, Pomona. She holds a graduate certificate in effective supervision from Cal Poly Pomona and is a member of the Orange County Regulatory Association, DIA, PDA, AGRE and RAPS.
Affiliations and expertise
Assistant Professor, Department of Regulatory and Quality Sciences, University of Southern California, Los Angeles, California, USA

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