An Overview of FDA Regulated Products

From Drugs and Cosmetics to Food and Tobacco

2nd Edition - March 26, 2025
Imprint: Academic Press
Editors: Eunjoo Pacifici, Susan Bain
Language: English
Paperback ISBN:
9 7 8 - 0 - 4 4 3 - 2 3 7 8 0 - 5
eBook ISBN:
9 7 8 - 0 - 4 4 3 - 2 3 7 8 1 - 2

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

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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.

Title of Book
Cover image
Title page
Table of Contents
Copyright
Dedication
List of contributors
About the editors
Foreword (From the first edition)
Preface
Acknowledgments
Chapter 1. Introduction to Food and Drug Administration regulated products
Abstract
Chapter objectives
1.1 What is a regulated product?
1.2 How are different products regulated?
1.3 Product classification
1.4 History of the modern regulatory system
1.5 Focus on postmarketing oversight
1.6 The modern regulatory system
References
Chapter 2. Regulatory agencies of the ICH: authorities, structures, and functions
Abstract
Chapter objectives
2.1 Introduction
2.2 United States: Food and Drug Administration
2.3 China: National Medical Products Administration
2.4 Japan: Ministry of Health Labour and Welfare and Pharmaceutical and Medical Devices Agency
2.5 European Union: European Medicines Agency
2.6 Roles of Council for International Organizations of Medical Sciences and International Council on Harmonization
AI disclosure
References
Further reading
Chapter 3. Drugs
Abstract
Chapter objectives
3.1 Is the product a drug?
3.2 How are drugs categorized?
3.3 What is a regulatory strategy and what does it entail?
3.4 What are the key steps of a new drug development process?
3.5 What are the key steps of a new drug approval process in the United States?
3.6 What happens after a drug product receives regulatory approval?
3.7 How is a new drug developed and approved in international markets?
3.8 What are the key steps of a generic drug development and approval process?
3.9 What are the key steps of an over-the-counter (OTC) drug development and approval process?
3.10 Emerging trends
References
Chapter 4. Biologics
Abstract
Chapter objectives
4.1 What is a biologic?
4.2 Which center at the Food and Drug Administration regulates biologics? Center for Biologic Evaluation and Research or Center for Drug Evaluation and Research?
4.3 What is Food and Drug Administration’s role regarding biological products?
4.4 How do biologics differ from conventional drugs?
4.5 The regulatory pathways (how do I bring a new biologic to approval?)
4.6 Submission and review process
4.7 Postmarketing activities
4.8 Special topics
4.9 Conclusions
References
Further reading
Chapter 5. Medical device and diagnostic products
Abstract
5.1 Regulating devices in the United States
5.2 Recent initiatives to encourage innovation
5.3 Regulatory strategy
5.4 Assuring compliant manufacturing
5.5 Conducting clinical trials
5.6 Gaining regulatory approval
5.7 Medical device regulation in other countries
5.8 In vitro diagnostics—a special type of medical device
5.9 International regulation of in vitro diagnostic products
Further reading
Chapter 6. Combination products, borderline products, and companion diagnostics
Abstract
Chapter objectives
6.1 What is a combination product or a companion diagnostic and why are these types of products so important?
6.2 Challenges for the regulation and classification of combination products and companion diagnostics
6.3 US perspective
6.4 European perspective
6.5 Regulation of companion diagnostics
6.6 Conclusion
References
Chapter 7. Food
Abstract
Key sections
Chapter objectives
7.1 Food regulatory history
7.2 Which agency is responsible for regulating food?
7.3 Key food regulatory standards
7.4 Adulteration
7.5 Misbranded
7.6 What is healthy?
7.7 Natural
7.8 Organic
7.9 Nutrition Labeling (United States)
7.10 Functional foods (United States)
7.11 Health claims
7.12 Bioengineered labeling
7.13 Safety Assessment (Generally Recognized as Safe)
7.14 New dietary ingredient
7.15 Clean labels (United States)
7.16 What is free?
7.17 Conclusion
References
Chapter 8. Veterinary products
Abstract
Chapter objectives
8.1 How are veterinary products regulated?
8.2 Animal drugs
8.3 Animal feeds
8.4 How are dietary supplements for animals regulated?
8.5 Veterinary devices
8.6 Veterinary biologics
8.7 Pesticides
8.8 Animal grooming aids
Reference
Further reading
Chapter 9. Dietary supplements
Abstract
Chapter objectives
9.1 How are dietary supplements regulated within the FDA?
9.2 What are dietary supplements?
9.3 What are new dietary ingredients?
9.4 How are dietary supplements labeled?
9.5 What claims may be made for dietary supplements?
9.6 What requirements apply to manufacturing and distributing dietary supplements?
9.7 What adverse event reporting requirements apply to dietary supplements?
9.8 How is advertising of dietary supplements regulated by the Federal Trade Commission and the states?
Further reading
Chapter 10. Cosmetics
Abstract
Chapter objectives
10.1 How are cosmetics defined?
10.2 Is it a cosmetic, a drug, or a cosmetic–drug?
10.3 How are cosmetics regulated?
10.4 Modernization of cosmetics regulation
10.5 State regulations for cosmetics
10.6 International considerations for cosmetics
10.7 Future regulatory outlook for cosmetics in the United States
References
Chapter 11. Tobacco products
Abstract
Chapter objectives
11.1 History of tobacco and tobacco control
11.2 History of tobacco product regulation
11.3 Tobacco Control Act
11.4 Center for Tobacco Products
11.5 Tobacco Products Scientific Advisory Committee
11.6 What is a “public health standard”?
11.7 How can tobacco products be marketed?
11.8 Sale and distribution
11.9 Other regulatory requirements
11.10 Conclusions
References
Chapter 12. Quality
Abstract
Chapter objectives
12.1 Background
12.2 Good laboratory practices for nonclinical laboratory studies
12.3 Good clinical practices
12.4 Good manufacturing practices
12.5 Quality systems for medical devices
12.6 Regulation and quality systems for cellular and gene therapies
12.7 Precision/personalized medicine
12.8 Digital health technologies
12.9 Conclusion
Chapter 13. Ensuring medical product safety
Abstract
Chapter objectives
13.1 Introduction
13.2 Pharmacovigilance practice
13.3 Regulatory agency approval of the benefit–risk balance
13.4 Managing signals
13.5 Conclusion
References
Index

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, USA Associate Director, D. K. Kim International Center for Regulatory Science, School of Pharmacy, University of Southern California, Los Angeles, CA, USA

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

Life Sciences

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