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JNCI Journal of the National Cancer Institute 2006 98(6):379-381; doi:10.1093/jnci/djj121
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© Oxford University Press 2006.

NEWS

Drug Safety System Needs Overhaul, Experts Say

Joel B. Finkelstein

The first 10% of the full text of this article appears below.

The system for establishing and monitoring the safety of new drugs is starting to show its age and will need substantial retooling if it is to better weed out problems before or soon after drugs hit the market, stakeholders told an Institute of Medicine panel.

At the request of the U.S. Food and Drug Administration, IOM formed an ad hoc committee to assess the current system for evaluating and ensuring drug safety after approval and make recommendations to improve risk assessment, surveillance, and the safe use of drugs. In January, the committee held the fourth of a year-long series of meetings, which will culminate in a report scheduled to be released in July.

The FDA request came in response to recent public concerns raised . . . [Full Text of this Article]


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