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Imperfect Information: Since Tumor Promotion By Prasugrel Was Unprovable, FDA Asked If It Was Biologically Plausible

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In a setting of imperfect information regarding the hot-button issue of whether prasugrel has a tumor promotion effect, FDA put greater weight on the explanatory powers of modes of assessment that are normally overshadowed by clinical evaluation.

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