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CV Outcomes Trials In Diabetes: First Results Suggest “Goalpost” Model Here To Stay

This article was originally published in RPM Report

Executive Summary

The first FDA advisory committee review of post-marketing cardiovascular outcomes trials conducted under the CV safety requirements imposed by the agency in 2008 ended with clear votes in favor of new warnings for the affected products – and a less explicit but no less clear endorsement of the approach spelled out in the guidelines.

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