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Longer, better studies of coronary stents are needed, FDA tells industry

BMJ 2008; 336 doi: http://dx.doi.org/10.1136/bmj.39537.837419.C2 (Published 03 April 2008) Cite this as: BMJ 2008;336:743
  1. Jeanne Lenzer
  1. 1New York

    After a year of controversy over the relative safety of drug eluting stents and bare metal stents, the US Food and Drug Administration has issued guidance to the industry on the development and testing of stents.

    It recommends that all clinical trials should have a follow-up period of 12 months, instead of the current nine months, and that a data monitoring committee should continuously review all studies of drug eluting stents. The agency, which issued the guidance last week, will accept public comments on the recommendations for 120 days before it issues its final guidance.

    Daniel Schultz, director of the agency’s Center for Devices and Radiological Health, said that the draft guidance “is part of …

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