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Congress wants FDA updates on drug safety changes

Executive Summary

Congress' FY 2005 omnibus spending bill (HR 4818) conference report chastises FDA for failing to promptly provide documents related to drug safety activities to House and Senate Appropriations Committees. "The conferees find it necessary to remind" FDA "that the committees on Appropriations perform critical oversight functions for the agency," the report states. "It is insupportable that in some cases FDA has given information about major policy matters to the press before providing the same information to Congress." The conferees request "regular progress reports" on the Institute of Medicine's review of FDA's post-marketing safety regulatory system (1"The Pink Sheet" Nov. 15, 2004, p. 8)...

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