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Why the Prasugrel Launch Was Worse Than it Looked: A Sentinel Case Study

This article was originally published in RPM Report

Executive Summary

FDA’s new Sentinel system is up and running, and the first examples of real world use of the “real world” post-marketing data network are being showcased. One example of compliance with patient selection criteria for Lilly’s Effient indicates some of the profound ways Sentinel may ultimately reshape regulation—but also suggests that the notoriously slow launch of prasugrel was even worse than it looked.

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