What is FDA doing about managing the risks associated with drug-eluting stents?
RB: FDA is leading a collaborative effort that, if successful, will result in a clinical trial to determine the best uses of anti-platelet drugs in patients receiving drug-eluting coronary stents. The collaboration involves multiple manufacturers, and I doubt that such a collaboration would be possible without FDA’s encouragement and sustained support. This is exactly the kind of effort that demonstrates the value of the Critical Path Initiative and its role in innovations and improved patient safety.
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