While on-time reviews are a key part of the Prescription Drug User Fee Act bargain between FDA and industry, circumstances sometimes conspire to make a missed user fee goal far more desirable than moving to a second review cycle – from both perspectives.
Erwinaze And The Blessings Of A Missed PDUFA Goal
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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