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BioPharmaceutical Clinical Trials Approvals

Erwinaze And The Blessings Of A Missed PDUFA Goal

This article was originally published in Pharmaceutical Approvals Monthly

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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