The Need for FDA Regulatory Reform to Protect the Health and Safety of Americans PDF Download
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Author: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 188
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Book Description
Author: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 188
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Book Description
Author: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 169
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Book Description
Author: Henry I. Miller, MD
Publisher: Hoover Institution Press
ISBN: 081799906X
Category : Political Science
Languages : en
Pages : 128
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Book Description
A government monopoly over drug regulation is not sacrosanct. This hard-hitting book describes the current regulation of drugs by the FDA and proposes a model for fundamental, yet workable, reform—including an innovative proposal for drug testing and certification review.
Author: United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 476
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Book Description
Author: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 176
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Book Description
Author: Philip J. Hilts
Publisher: Knopf
ISBN: 9780375404665
Category : Health & Fitness
Languages : en
Pages : 394
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Book Description
Provides a detailed history of the Food and Drug Administration as it evolved into America's most important regulatory agency, designed to protect the nation from hazardous medicines and food products.
Author: Committee to Ensure Safe Food from Production to Consumption
Publisher: National Academies Press
ISBN: 0309593409
Category : Medical
Languages : en
Pages : 209
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Book Description
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.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309163587
Category : Medical
Languages : en
Pages : 589
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157277
Category : Medical
Languages : en
Pages : 335
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Book Description
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309184134
Category : Medical
Languages : en
Pages : 158
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Book Description
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.
