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FDA News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDA responds to drug-eluting stent concerns: Agency announces public meeting of the Circulatory System Devices Advisory Panel by year-end to address mounting concerns about late stent thrombosis prompted by the release of new data at the European Society of Cardiology/World Congress of Cardiology meeting in Barcelona this month and the American College of Cardiology scientific sessions in Atlanta in March. FDA aims to deepen understanding of late stent thrombosis and gauge correct duration of antiplatelet-drug regimens for drug-eluting stent recipients. Still, FDA stands by the safety and efficacy of the Cypher (J&J/Cordis) and Taxus (Boston Scientific) drug-eluting stents when used for approved indications. Boston Scientific, which recently reported a slightly higher risk of clots for Taxus compared to bare-metal stents, will disclose 48-month results from clinical trials at the Transcatheter Cardiovascular Therapeutics meeting Oct. 22-27 in Washington, D.C....

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Cardiologists Want Concrete Guidance From FDA Panel On Stent Thrombosis

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MDMA Annual Meeting In Brief

CED is coming soon: Revised draft guidance on CMS' coverage-with-evidence development policy is expected out within "weeks," agency Administrator Mark McClellan said June 15 at the Medical Device Manufacturers Association annual meeting in Washington, D.C. Despite rumors following the first draft guidance that CED was dead in the water due to concerns about basing coverage on patient consent, the new version will address the issue (1"The Gray Sheet" May 8, 2006, p. 7). "We want to get this right," McClellan said...

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