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DEVICES EXCLUDED FROM FDA CLINICAL TRIALS DATABASE FOR AT LEAST TWO YEARS UNDER SENATE FDA REFORM BILL; HOUSE REFORM MEASURE SLATED FOR VOTE OCT. 6 OR 7

This article was originally published in The Gray Sheet

Executive Summary

Device manufacturers get a reprieve of at least two years on inclusion of clinical trial data in a public FDA database under the "FDA Modernization and Accountability Act of 1997" (S 830) approved by the Senate Sept. 24 ("The Gray Sheet" Sept. 29, p. 3).
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