PDUFA VI "Breakthrough" Fee Unlikely; US FDA Wants Fewer Obligations, Not New Metrics
This article was originally published in SRA
Officials of the US Food and Drug Administration negotiating the Prescription Drug User Fee Act VI (PDUFA VI) agreement say they would be hesitant to ask for user fees from the pharmaceutical industry specifically to fund the "breakthrough designation program" - even if the fees would help offset the agency's unexpectedly heavy workload and reduce the number of unqualified requests for the designation1,2.
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