Healthy Skepticism Library item: 9999
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Hennessy S, Strom BL.
PDUFA reauthorization--drug safety's golden moment of opportunity?
N Engl J Med 2007 Apr 26; 356:(17):1703-4
http://content.nejm.org/cgi/content/full/356/17/1703
Abstract:
“This [is] a golden moment of opportunity to improve fundamentally the way FDA regulation considers and responds to the evolving understanding of risks and benefits of drugs.” So claims the September 2006 Institute of Medicine (IOM) report entitled The Future of Drug Safety, which paints a dismal picture of the U.S. system for ensuring the safety of drugs after they have been approved by the Food and Drug Administration (FDA).1 Among the more easily remediable shortcomings identified by the IOM are the severe underfunding of the FDA, the particularly poor funding for postapproval monitoring of safety, and the “troubling imbalance” between these resources and those available for preapproval review…
Keywords:
MeSH Terms:
Drug Approval/economics
Drug Approval/legislation & jurisprudence*
Drug Industry/economics*
Drug Industry/legislation & jurisprudence
Fees and Charges*
Government Regulation
Humans
Product Surveillance, Postmarketing/economics*
United States
United States Food and Drug Administration/economics
United States Food and Drug Administration/legislation & jurisprudence*
United States Food and Drug Administration/organization & administration
Notes:
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