FDA, Medicare Launch Drug Safety Initiative

Law360, New York (May 23, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration and Medicare have joined forces in an attempt to detect safety problems from drug and medical devices more quickly by mining the millions of medical records held by the two agencies.

The two announced a new “Sentinel Initiative” on Thursday, which would enable the FDA to analyze a growing number of health record databases compiled by the government, health insurers and HMOs to assess the risk of drugs already on the market.

Under the current system, which relies on voluntary...
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