Healthy Skepticism Library item: 10000
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Publication type: Journal Article
McClellan M.
Drug safety reform at the FDA--pendulum swing or systematic improvement?
N Engl J Med 2007 Apr 26; 356:(17):1700-2
http://content.nejm.org/cgi/content/full/356/17/1700
Abstract:
Every 5 or 10 years, Congress enacts major legislation addressing pressing issues at the Food and Drug Administration (FDA). This year, the biggest reforms since at least 1997 are expected. A decade ago, reform was motivated by the perception that the agency wasn’t getting new medicines to patients as efficiently as possible. Today, a leading concern is that it isn’t protecting the public from drugs’ risks as effectively as it might…
Keywords:
MeSH Terms:
Drug Approval/economics
Drug Approval/legislation & jurisprudence*
Drug Industry/economics
Drug Industry/legislation & jurisprudence*
Fees and Charges
Government Regulation
Health Care Reform/legislation & jurisprudence
Humans
Prescriptions, Drug
Product Surveillance, Postmarketing*
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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