Food and Drug Legislation in the New Deal

Food and Drug Legislation in the New Deal
Author: Charles O. Jackson
Publisher: Princeton University Press
Total Pages: 262
Release: 2015-03-08
Genre: Technology & Engineering
ISBN: 1400869609

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In June 1938, Franklin D. Roosevelt signed into law a new Food, Drug, and Cosmetic Act, the first major legislation regulating these industries since the 1906 Wiley law. Eliminating many serious and long-standing abuses in production, labeling, and advertising, the 1938 Act was, in the words of David L. Cowen, "a milestone in federal interest in consumer protection." Despite its importance to the American public, however, its passage was effected only after a long, complex battle between conflicting interest groups. This volume is a study in depth of that five-year struggle, fully documented by records, correspondence, and publications, as well as a social history of the period. The author analyzes the inadequacy of the 1906 law, the roles of Franklin Roosevelt, Henry Wallace, and Rexford Tugwell, the American Medical Association, drug associations, and consumers' and women's groups. Originally published in 1970. 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.

The Jungle

The Jungle
Author: Upton Sinclair
Publisher:
Total Pages: 442
Release: 1920
Genre: Chicago (Ill.)
ISBN:

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Federal Regulation of Methadone Treatment

Federal Regulation of Methadone Treatment
Author: Committee on Federal Regulation of Methadone Treatment
Publisher: National Academies Press
Total Pages: 251
Release: 1995-02-01
Genre: Medical
ISBN: 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.

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

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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.

Food and Drug Administration Advisory Committees

Food and Drug Administration Advisory Committees
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 239
Release: 1992-02-01
Genre: Medical
ISBN: 0309048370

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Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.