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In Brief: FDA reform

This article was originally published in The Tan Sheet

Executive Summary

FDA reform: House Commerce Committee FDA reform legislation expected to be marked up by mid-July, with the goal of having a bill through the House in time for conference before the August recess, set to begin Aug. 2. The Senate FDA Reform/Prescription Drug User Fee Act reauthorization bill (S 830) was reported out of committee June 18 ("The Tan Sheet" June 23, p. 14). The House continues to pursue a two-track approach to FDA reform, with medical device-related reform included in a separate bill from PDUFA/drug reform. Senate floor debate on S 830 is expected in mid-July. The drafting process for the Commerce Committee bill is expected to be completed during the June 28-July 7 recess. The committee mark-up may be of Rep. Richard Burr's (R-N.C.) reintroduced drug reform bill (HR 3199) ("The Tan Sheet" Jan. 27, p. 22)...
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