FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

A Practical Guide to FDA's Food and Drug Law and Regulation provides an introduction to the laws and regulations governing development, marketing, and sale of food, medical products, tobacco, and cosmetics. Structured to serve as a reference and as a teaching tool, each chapter builds sequentially from the last, while providing an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. Written in real-world language, the book offers practical legal/regulatory fundamentals for use by a wide range of people interested in the FDA legal and regulatory scheme. This book is a standard text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including a U.S. Supreme Court opinion). This Sixth Edition incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances. It also incorporates important changes that have resulted from recent court opinions and administrative enforcement actions.

Pharmacy Practice

As conscientious consumers, we become overwhelmed with alarms about food contamination, climate change, chemical pollution and other environmental and health-related risks. This book explores green and politically engaged consumersim, asking the question: does green labelling offer ways toward a greener and more democratic society?