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Volume 355:1753-1755 October 26, 2006 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.

	Full Text PDF PDA Full Text Interview Editorial by Curfman, G. D. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

Soon after rofecoxib had been withdrawn from the market in September 2004, hearings of the Senate Finance Committee and editorials in the lay and medical press raised serious questions about drug safety in the United States. In response, the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to assess the U.S. drug-safety system. The IOM assembled a diverse panel of experts without ostensible bias or conflict of interest, none of whom were pharmaceutical industry employees. The committee, on which we served, reviewed published literature, held open meetings, and . . . [Full Text of this Article]

Toward a New Vision of Drug Safety

Source Information

Dr. Psaty is a professor and codirector of the Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle. Ms. Burke is an adjunct lecturer at the Kennedy School of Government, Harvard University, Cambridge, MA, and deputy secretary and chief operating officer of the Smithsonian Institution, Washington, DC. Ms. Burke was the chair of, and Dr. Psaty a member of, the Institute of Medicine Committee on the Assessment of the U.S. Drug Safety System.

A list of IOM committee members and staff is included in the report brief, "The Future of Drug Safety: Action Steps for Congress" at www.iom.edu/CMS/3793/26341/37329/37331.aspx.

An interview with Dr. Psaty can be heard at www.nejm.org.

This article was published at www.nejm.org on October 9, 2006.

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