Reauthorization of the Prescription Drug User Fee Act and FDA Reform
Author: United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment
Publisher:
Published: 1997
Total Pages: 200
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment
Publisher:
Published: 1997
Total Pages: 200
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
Published: 2008
Total Pages: 128
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
Published: 2002
Total Pages: 134
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Commerce
Publisher:
Published: 1997
Total Pages: 144
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DOWNLOAD EBOOK →Author: Institute of Medicine
Publisher: National Academies Press
Published: 2007-02-27
Total Pages: 346
ISBN-13: 0309133947
DOWNLOAD EBOOK →In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2017-09-28
Total Pages: 483
ISBN-13: 0309459575
DOWNLOAD EBOOK →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. Congress. House. Committee on Commerce
Publisher:
Published:
Total Pages: 624
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Commerce
Publisher:
Published: 1999
Total Pages: 136
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DOWNLOAD EBOOK →Author: ADAM I. MUCHMORE
Publisher:
Published: 2021-03-14
Total Pages: 734
ISBN-13: 9781531004453
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
Published: 2008
Total Pages: 320
ISBN-13:
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