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Bristol-Myers Squibb/AstraZeneca Onglyza is Guinea Pig for FDA Mini-Sentinel Post-Market Surveillance

This article was originally published in RPM Report

Executive Summary

FDA’s Congressionally-mandated active surveillance system, Sentinel, is ready for shakedown cruises in 2011. One of the first projects will be a close examination of real-world experience and cardiovascular events associated with saxagliptin. That’s a dubious distinction for BMS/AZ, the co-marketers of Onglyza–but it also sets up a new dynamic that all sponsors should watch.

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