An Overview of FDA Regulated Products
From Drugs and Cosmetics to Food and Tobacco

Translates complex regulatory concepts using case studies, examples and key points to provides a valuable overview of the regulations, systems and processes governing an array of FDA regulated products

Eunjoo Pacifici (Edited by), Susan Bain (Edited by)

9780128111550, Elsevier Science

Paperback, published 19 June 2018

280 pages
23.4 x 19 x 1.9 cm, 0.57 kg

Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful.

1. Introduction to Regulated Products 2. Regulatory Agencies of the ICH: Authorities, Structures and Functions 3. Drugs 4. Biologics 5. Medical Devices and Diagnostic Products 6. Combination Products, Borderline Products and Companion Diagnostics 7. Food 8. Veterinary Products 9. Dietary Supplements 10. Cosmetics 11. Tobacco Products 12. Quality

Subject Areas: Biotechnology [TCB], Pharmacology [MMG]