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Volume 357:960-963 September 6, 2007 Number 10
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Sidelining Safety — The FDA's Inadequate Response to the IOM
Sheila Weiss Smith, Ph.D.

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Having been commissioned by the Food and Drug Administration (FDA) to evaluate the U.S. drug-safety system, the Institute of Medicine (IOM) published a report, The Future of Drug Safety, in September 2006 identifying weaknesses in the laws, regulations, resources, and practice of ensuring drug safety.1 Some of the IOM's recommendations were directed toward Congress, which it believed should increase FDA funding and regulatory authority. Some outlined ways in which other federal agencies could work in partnership with the FDA for the public good. But most of the report outlined deficiencies that the FDA itself — or the Department of Health . . . [Full Text of this Article]


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Dr. Smith is an associate professor at the Center on Drugs and Public Policy, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, and in the Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine — both in Baltimore.


Related Letters:

The FDA and the IOM Report
Galson S. K., Smith S. W.
Extract | Full Text | PDF  
N Engl J Med 2007; 357:2520-2522, Dec 13, 2007. Correspondence

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