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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.


Enhancing Food Safety

Enhancing Food Safety
Author: National Research Council
Publisher: National Academies Press
Total Pages: 589
Release: 2010-11-04
Genre: Medical
ISBN: 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.


The Great American Fraud

The Great American Fraud
Author: Samuel Hopkins Adams
Publisher: Createspace Independent Publishing Platform
Total Pages: 184
Release: 1907
Genre: History
ISBN:

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This is the introductory article to a series which will contain a full explanation and exposure of patent-medicine methods, and the harm done to the public by this industry, founded mainly on fraud and poison. Results of the publicity given to these methods can already be seen in the steps recently taken by the National Government, some State Governments and a few of the more reputable newspapers. The object of the series is to make the situation so familiar and thoroughly understood that there will be a speedy end to the worst aspects of the evil.