BMJ 2008;336:743 (5 April), doi:10.1136/bmj.39537.837419.C2
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Longer, better studies of coronary stents are needed, FDA tells industry
Jeanne Lenzer
1 New York
| The first 150 words of the full text of this article appear below. |
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Daniel Schultz, director of the agency’s Center for Devices and Radiological Health, said that the draft guidance "is part of FDA’s ongoing effort to provide regulated industry with recommendations on measures that can minimise the risks while preserving for patients the benefits of drug eluting stents."
The guidance comes in response to a fractious debate
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- When will NICE or the FDA make stent manufacturers prove they are not merely latter day snake oil salesmen?
- Professor Michael R Chester, et al.
bmj.com, 9 Apr 2008 [Full text]
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