FDCA Statutory Supplement, 2021 (2nd Edition)

FDCA Statutory Supplement, 2021 (2nd Edition)
Author: Emily Strunk
Publisher:
Total Pages:
Release: 2021-05-31
Genre:
ISBN: 9781935065937

The FDCA Statutory Supplement, 2021 is an indispensable tool for FDA law practitioners. This publication provides cross-referencing of the numerous legislative amendments with the original statute, facilitating quick research and citation, and highlights recent changes through simple formatting. This edition is updated to incorporate the CARES Act and other statutory amendments since the 2018 edition. The appendix contains relevant portions of related statutes. This publication is available in both print and E-book versions.

FDCA Statutory Supplement, 2018

FDCA Statutory Supplement, 2018
Author: Joy J. Liu
Publisher:
Total Pages: 662
Release: 2018-02-07
Genre: Law
ISBN: 9781935065869

The FDCA Statutory Supplement, 2018 is the indispensable tool for FDA law practitioners. Cross-referencing of the numerous legislative amendments with the original statute facilitates quick research and citation, and recent changes are highlighted with simple formatting. Access to an electronic version is included with each print copy.

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
Author: Eunjoo Pacifici
Publisher: Academic Press
Total Pages: 292
Release: 2018-06-13
Genre: Medical
ISBN: 0128111569

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. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Dietary Supplements

Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
Total Pages: 32
Release: 1998
Genre: Advertising
ISBN:

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
Author: Stephen M. Kanovsky
Publisher:
Total Pages: 672
Release: 2020-09
Genre: Drugs
ISBN: 9781935065876

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.