FDA Issues Warning Letter to Boston Scientific

The U.S. Food and Drug Administration issued a warning letter last week to Natick, Mass.-based Boston Scientific about serious problems in two clinical trials, the company disclosed Friday. The clinical trials involved experimental stent grafts used to treat abdominal aortic aneurysms, and the problems ranged from a failure to investigate two patient deaths to a lack of prompt notice to FDA and clinical investigators about other problems, according to an Aug. 30 letter by FDA.
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