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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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Effient Review Delayed More By Management Issues Than Clinical Disputes

In FDA’s review of Lilly/Daiichi Sankyo’s antiplatelet agent Effient (prasugrel) – a drug with broad potential use – it is notable that the approval was delayed not by unusual clinical questions, but rather by the agency’s efforts to be exceedingly thorough and scrupulous in the review.

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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