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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher : Unknown
Page : 140 pages
File Size : 46,6 Mb
Release : 1991
Category : Political Science
ISBN : LOC:00185454198
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 42,6 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570
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.
Author : Institute of Medicine,Committee to Study the Use of Advisory Committees
Publisher : National Academies Press
Page : 239 pages
File Size : 44,8 Mb
Release : 1992-02-01
Category : Medical
ISBN : 9780309048378
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.
Author : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment
Publisher : Unknown
Page : 502 pages
File Size : 40,9 Mb
Release : 1972
Category : Food adulteration and inspection
ISBN : LOC:00184237313
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher : Unknown
Page : 128 pages
File Size : 53,8 Mb
Release : 1991
Category : Electronic
ISBN : SRLF:AA0006152730
Author : National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Committee on the Review of the Food and Drug Administration's Role in Ensuring Safe Food
Publisher : National Academies Press
Page : 589 pages
File Size : 51,9 Mb
Release : 2010-11-04
Category : Medical
ISBN : 9780309163583
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 : United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 84 pages
File Size : 53,6 Mb
Release : 1998
Category : Law
ISBN : LOC:00186245878
Author : Lisa Shames
Publisher : DIANE Publishing
Page : 74 pages
File Size : 41,5 Mb
Release : 2010-06
Category : Health & Fitness
ISBN : 9781437930092
FDA is not required to review substances, such as spices and preservatives, added to food that are Generally Recognized as Safe (GRAS) for their intended use. A few substances previously considered GRAS have later been banned; and concerns have been raised about the safety of other GRAS substances, including materials manufactured at a tiny scale to take advantage of novel properties. This report reviewed the extent to which: (1) FDA's oversight of new GRAS determinations helps ensure the safety of these substances; (2) FDA ensures the continued safety of current GRAS substances; and (3) FDA's approach to regulating engineered nano-materials in GRAS substances helps ensure the safety of the food supply. Illus.
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 81 pages
File Size : 41,7 Mb
Release : 2010
Category : Medical
ISBN : 9781437920703
Twenty years ago, it was reported that the FDA was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products -- human drugs, biologics, and medical devices -- marketed for sale in the U.S. Since then, concerns have been raised regarding FDA's ability to meet its oversight responsibilities. This report reviews the resources supporting FDA's medical product oversight responsibilities. It examines trends in: (1) FDA's funding and staffing resources for its medical product oversight responsibilities from FY 1999 through 2008; and (2) FDA's medical product oversight responsibilities during this same period. Charts and tables.
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 830 pages
File Size : 45,5 Mb
Release : 2008
Category : Business & Economics
ISBN : UCBK:C099225197
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 176 pages
File Size : 40,9 Mb
Release : 1993
Category : Business & Economics
ISBN : UCR:31210014075616
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams
Publisher : National Academies Press
Page : 353 pages
File Size : 54,5 Mb
Release : 2020-07-21
Category : Medical
ISBN : 9780309672184
Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 272 pages
File Size : 50,7 Mb
Release : 1982
Category : Consumer protection
ISBN : LOC:00019003693
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 324 pages
File Size : 51,5 Mb
Release : 2007
Category : Medical
ISBN : PSU:000061493315
Author : United States. Congress. House. Interstate and Foreign Commerce
Publisher : Unknown
Page : 496 pages
File Size : 44,6 Mb
Release : 1972
Category : Electronic
ISBN : STANFORD:36105045432270