Discussion Drafts Concerning Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, Drug Safety, and Certain Pediatric Pharmaceutical and Device Legislation PDF Download
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Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 320
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Book Description
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 320
Get Book Here
Book Description
Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category : Energy policy
Languages : en
Pages : 312
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Book Description
Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category :
Languages : en
Pages : 312
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Book Description
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 310
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Book Description
Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 448
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Book Description
Author: United States. Congress
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 924
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Book Description
Author: United States. Congress
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 922
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
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 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: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
