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Erwinaze And The Blessings Of A Missed PDUFA Goal

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

CDER missed one user fee goal for action in its 2011 novel approvals – EUSA Pharma’s Erwinaze – and running long allowed the agency and sponsor to find a work-around to a clinical problem that could otherwise have entailed time-consuming new investigations.

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