Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 172

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Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

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Book Description
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: National Research Council
Publisher: National Academies Press
ISBN: 0309163587
Category : Medical
Languages : en
Pages : 589

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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.

Author: Meredith A. Hickmann
Publisher: Nova Publishers
ISBN: 9781590333877
Category : Business & Economics
Languages : en
Pages : 212

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The FDA is responsible for ensuring the safety of foods, drugs, medical devices, cosmetics, and a variety of other products. These products account for 25 cents of every dollar US consumers spend. Under the authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that these products are safe, accurately labelled, and in the case of drugs and medical devices, effective. FDA's tasks include: enforcement, pre-market product evaluation and approval, post-market surveillance and investigations, publishing of regulations, conducting and monitoring of research, public education, and regulating products and processes to prevent hazards to human health. Contents: Preface; Food and Drug Administration: Selected Funding Data; Food and Drug Administration: Selected Funding and Policy Issues; US European Agricultural Trade: Food and Biotechnology Issues; Food and Drug Administration: Selected Funding and Policy Issues; Food and Drug Administration Modernisation Act of 1997 -- The Provisions; Index.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318

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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 184

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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309172802
Category : Medical
Languages : en
Pages : 88

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In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309183642
Category : Medical
Languages : en
Pages : 135

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The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

Author: George E. MacKinnon III
Publisher: Jones & Bartlett Publishers
ISBN: 1449673945
Category : Medical
Languages : en
Pages : 241

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Book Description
Understanding Health Outcomes and Pharmacoeconomics presents an overview of the tools used to assess patient-related health status including associated health outcomes and the analyses that are used to determine cost-effectiveness in evaluating pharmacotherapeutic interventions to improve health. Including data and examples from several different countries, this comprehensive text will help students understand the basis for decisions made at the local and governmental level that impact the use of pharmaceuticals and provide a strong foundation for understanding the principles used in cost-effective decision making. With commentaries, cases studies, and highlighting international differences, this text concludes with a discussion of the need for a universal system for documenting medication use. Understanding Health Outcomes and Pharmacoeconomics provides definitions of comparative effectiveness research (CER) and comparisons of pharmacoeconomic models (including cost-effectivess, cost-benefit, and cost utility analyses). This inclusive text provides describes how CER is linked to various pharmacoeconomic models by providing examples from clinical trials with comparative pharmacotherapy and cost parameters. From the Introduction: "The need for interprofessional education was made apparent in the 2003 Health Professions Education: A Bridge to Quality report. All healthcare professionals must be educated to deliver patient-centered care as members of an interprofessional team, emphasizing evidence-based practice, quality improvement approaches, and informatics. An enhanced understanding of pharmacoeconomic principles is a step in the right direction for healthcare practitioners as we do our best to ensure optimal medication therapy outcomes for patients and society at-large." -- George E. MacKinnon III, PhD, RPh, FASHP

Author: United States. Congress
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 106

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