Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco

Purpose of this Book: This comprehensive food and drug law resource, “Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products Regulation,” is organized for ease of reading in order to comprehend a complex area of law. This easy to navigate treatise is well-ordered into separate volumes with a concise introduction to provide a particular focus for the reader. This reference contains a distinct volume for each subject based on regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related law. This entire work serves as an inclusive resource for:

The regulated industry such as legal counsel and regulatory affairs professionals searching for concise explanations of relevant portions of the Food, Drug and Cosmetic Act (FDCA);

Legal practitioners whose practice involves food, medical devices, drugs, biologics, personal care, veterinary, dietary supplements and tobacco products regulatory law;

Government personnel—federal, state and local involved in these topics;

Attorneys in related disciplines who find themselves in the crosshairs of the FDCA; and

The academic community including professors and students searching for a clear resource.

The titles of each volume contained in this book are as follows:

Volume I: The “Why” of the United States Food and Drug Administration, Landmark Legislation, and Court Decisions

Volume II: Food and Drug Law Administrative Primer

Volume III: The Food and Drug Administration—Criminal and Civil Enforcement Strategies

Volume IV: Medical Device and Radiation Emitting Products Regulation

Volume V: Human Drug Regulation—Approvals, Promotion, Marketing, Warnings, Accountability, and Post-market Surveillance

Volume VI: Biotechnology and Biologic Products Regulation

Volume VII: Veterinary Products Regulation

Volume VIII: Personal Care Products Regulation—Safety, Product Classification and Enforcement

Volume IX: Food Regulation—Food Safety, Recalls, Claims, Additives, Allergens and Biotechnology

Volume X: Dietary Supplements, Herbs and Botanicals Regulation

Volume XI: Tobacco Products Regulation

Volume XII: Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future