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 PDF

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.

Ensuring Safe Food

Ensuring Safe Food PDF

Author: Committee to Ensure Safe Food from Production to Consumption

Publisher: National Academies Press

Published: 1998-09-02

Total Pages: 209

ISBN-13: 0309593409

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How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.

Enhancing Food Safety

Enhancing Food Safety PDF

Author: National Research Council

Publisher: National Academies Press

Published: 2010-11-04

Total Pages: 589

ISBN-13: 0309163587

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Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

Pure Food

Pure Food PDF

Author: James Harvey Young

Publisher: Princeton University Press

Published: 2014-07-14

Total Pages: 335

ISBN-13: 1400860326

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"Pure food" became the rallying cry among a divergent group of campaigners who lobbied Congress for a law regulating foods and drugs. James Harvey Young reveals the complex and pluralistic nature not only of that crusade but also of the broader Progressive movement of which it was a significant strand. In the vivid style familiar to readers of his earlier works, The Toadstool Millionaires and The Medical Messiahs, Young sets the pure food movement in the context of changing technology and medical theory and describes pioneering laws to control imported drugs and domestic oleomargarine. He explains controversy within the pure food coalition, showing how farming and business groups sought competitive commercial advantage, while consumer advocates wished to promote commercial integrity and advance public health. The author focuses on how the public became increasingly fearful of hazards in adulterated foods and narcotic nostrums and how Congress finally achieved the compromises necessary to pass the Food and Drugs Act and the meat inspection law of 1906. Originally published in 1989. The Princeton Legacy Library uses the latest print-on-demand technology to again make available previously out-of-print books from the distinguished backlist of Princeton University Press. These editions preserve the original texts of these important books while presenting them in durable paperback and hardcover editions. The goal of the Princeton Legacy Library is to vastly increase access to the rich scholarly heritage found in the thousands of books published by Princeton University Press since its founding in 1905.

Federal Regulation of Methadone Treatment

Federal Regulation of Methadone Treatment PDF

Author: Committee on Federal Regulation of Methadone Treatment

Publisher: National Academies Press

Published: 1995-02-01

Total Pages: 251

ISBN-13: 0309598621

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For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.