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

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.

It does not take much to elicit criticism from Center for Drug Evaluation & Research Deputy Director Bob Temple on observational and meta-analysis studies as serious regulatory tools.

At a recent Institute of Medicine meeting on “Characterizing and Communicating Uncertainty” in FDA’s benefit/risk decisions, Temple described the reluctance to consider sources of information beyond randomized

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