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Previous Volume 356:1703-1704 April 26, 2007 Number 17 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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"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" . . . [Full Text of this Article]

Source Information

Dr. Hennessy is an assistant professor and Dr. Strom a professor at the Center for Clinical Epidemiology and Biostatistics and the Centers for Education and Research on Therapeutics, University of Pennsylvania School of Medicine, Philadelphia.

This article (10.1056/NEJMp078048) was published at www.nejm.org on April 13, 2007.

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