A Practical Guide to FDA's Food and Drug Law and Regulations

The Fourth Edition of A Practical Guide to FDA's Food and Drug Law and Regulation updates and expands the widely-used Third Edition, including coverage of new laws on biosimilars, tobacco and food safety. A Practical Guide remains the single best resource for both practitioners and academics needing a basic, easy-to-use overview of the many laws and regulations administered and enforced by the Food and Drug Administration. This book encompasses food and drug law, beginning with a historical background, philosophy, and organization of food and drug law and how it works. Other chapters include information about combination products, dietary supplements and inspections. The goal of this fourth edition of A Practical Guide to FDA's Food and Drug Law and Regulation is to explain the law and regulations that govern the development, marketing, and sale of food, medical products, and cosmetics in simple, nontechnical terms.