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Pradaxa Medicare Study: Observing a Slow Attitude Change at FDA on Observational Studies

This article was originally published in RPM Report

Executive Summary

CDER Deputy Director Bob Temple is a confirmed skeptic of the value of observational trial data to FDA’s regulatory decisions. A recent Medicare study on the bleeding risks associated with Boehringer-Ingelheim’s Pradaxa, however, confirmed an earlier position on the drug by FDA and meets with Temple’s approbation.

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