Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 424

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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: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1568

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First multi-year cumulation covers six years: 1965-70.

Author: United States. Superintendent of Documents
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1092

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Book Description
February issue includes Appendix entitled Directory of United States Government periodicals and subscription publications; September issue includes List of depository libraries; June and December issues include semiannual index

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

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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: United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 796

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Author: ADAM I. MUCHMORE
Publisher:
ISBN: 9781531004453
Category :
Languages : en
Pages : 734

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Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1384

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Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 482

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Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1388

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Book Description