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Daniel Schultz, director of the agency’s Center for Devices and Radiological Health, said that the draft guidance “is part of …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