A Practical Guide to FDA’s Food and Drug Law Regulation, 5th Edition

Softbound | 520 Pages
Edited by Pines and Pina

The goal of this fifth 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. The Fifth Edition of A Practical Guide to FDA’s Food and Drug Law and Regulation updates and expands the widely-used Fourth Edition, including coverage of biosimilars, Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the Drug Quality and Security Act (DQSA) of 2013 and a new chapter devoted to animal drugs. 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.

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