The Institute of Medicine's report on drug safety: constructive and ambitious, but does it go far enough?
In September 2004, controversy surrounded the Food and Drug Administration (FDA). It climaxed more than a decade of safety concerns involving legitimate and perceived problems with FDA-approved drugs. In response, the FDA's Center for Drug Evaluation and Research (CDER) asked the Institute of Medicine (IOM) to examine the current systems for ensuring drug safety and recommend specific actions and improvements.
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The Degge Group, Ltd., Drug Safety, Arlington, Virginia, USA. jkjones@deggegroup.com
D004341:Drug Evaluation; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D017598:Efficiency, Organizational / Q000592:standards; D006801:Humans; D038622:Internationality; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards