Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act

Author: Mindy J. Allport-Settle

Publisher: Pharmalogika

Published: 2010-10

Total Pages: 672

ISBN-13: 9780983071907

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This book is designed to be a unified reference source for the U.S. Federal Food, Drug, and Cosmetic Act and is designed to be used both as a reference for experienced industry representatives and as a training resource for those new to the industry. Federal Food, Drug, and Cosmetic Act: * Introduction to the FDA and the FD&C Act * Part I: Federal Food, Drug, and Cosmetic Act o Section Number Reference: Federal Food, Drug, and Cosmetic Act o FD&C Act Chapters I and II: Short Title and Definitions o FD&C Act Chapter III: Prohibited Acts and Penalties o FD&C Act Chapter IV: FoodFD&C Act Chapter V: Drugs and Devices o FD&C Act Chapter VI: Cosmetics o FD&C Act Chapter VII: General Authority o FD&C Act Chapter VIII: Imports and Exports o FD&C Act Chapter IX: MiscellaneousSignificant Amendments to the FD&C Act Reference Tools * Part II: Combined Glossary and Index for all Regulations

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:

Published: 2020-09

Total Pages: 672

ISBN-13: 9781935065876

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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.

An Overview of FDA Regulated Products
An Overview of FDA Regulated Products

Author: Eunjoo Pacifici

Publisher: Academic Press

Published: 2018-06-13

Total Pages: 292

ISBN-13: 0128111569

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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

The Food and Drug Administration (FDA)
The Food and Drug Administration (FDA)

Author: Meredith A. Hickmann

Publisher: Nova Publishers

Published: 2003

Total Pages: 212

ISBN-13: 9781590333877

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The FDA is responsible for ensuring the safety of foods, drugs, medical devices, cosmetics, and a variety of other products. These products account for 25 cents of every dollar US consumers spend. Under the authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that these products are safe, accurately labelled, and in the case of drugs and medical devices, effective. FDA's tasks include: enforcement, pre-market product evaluation and approval, post-market surveillance and investigations, publishing of regulations, conducting and monitoring of research, public education, and regulating products and processes to prevent hazards to human health. Contents: Preface; Food and Drug Administration: Selected Funding Data; Food and Drug Administration: Selected Funding and Policy Issues; US European Agricultural Trade: Food and Biotechnology Issues; Food and Drug Administration: Selected Funding and Policy Issues; Food and Drug Administration Modernisation Act of 1997 -- The Provisions; Index.

Food Labeling
Food Labeling

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1992-02-01

Total Pages: 256

ISBN-13: 0309047374

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The Nutrition Labeling and Education Act of 1990 (NLEA) changed the existing regulatory framework for food labeling requirements that was shared among federal, state, and local levels of government. In addition to creating a system of mandatory nutrition labeling for foods, NLEA provided a schedule for the preemption of state and local labeling requirements that were not identical to federal provisions. Six provisions were not to be preempted until a study on the adequacy of the federal implementation of those provisions was completed. Food Labeling is the result of that study. It presents recommendations concerning the Food and Drug Administration's implementation of the six provisions that were studied, suggestions for the future disposition of relevant state and local food labeling requirements, and views on the continuing importance of the working relationship among the various levels of government in assuring that consumers are protected from misleading label information.

Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies
Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1999-04-29

Total Pages: 158

ISBN-13: 0309184134

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The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.

Pain Management and the Opioid Epidemic
Pain Management and the Opioid Epidemic

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-09-28

Total Pages: 483

ISBN-13: 0309459575

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Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.