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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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Secondary Uses of Sentinel

FDA’s new drug safety surveillance system is up and running, though the implications for safety oversight are only just beginning to be felt. But the conversation is already under way about what else Sentinel can do—and the answers may be very important to the future of drug regulation.

FDA Re-arms DSaRM: Recruits Eight Veterans from Safety/Surveillance World

The new group of Drug Safety & Risk Management Advisory Committee members comprises a lot of familiar faces. FDA has made use of its extensive outside academic connections, research grants and post-graduate training programs to bring in eight members for the Classes of 2013 and 2014. Most of them have been getting extensive on-the-job training with the advisory committee already.

FDA Re-arms DSaRM: Recruits Eight Veterans from Safety/Surveillance World

The new group of Drug Safety & Risk Management Advisory Committee members comprises a lot of familiar faces. FDA has made use of its extensive outside academic connections, research grants and post-graduate training programs to bring in eight members for the Classes of 2013 and 2014. Most of them have been getting extensive on-the-job training with the advisory committee already.

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