User Fee Delinquencies Rising At US FDA After PDUFA Redesign

Prescription drug user fee "receivables" nearly doubled in FY 2018, but the US FDA is not worried.

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Obligations for PDUFA funds were more than collections in FY 2018, forcing the agency to use some of its carryover balance. • Source: Shutterstock

The redesigned prescription drug user fee structure may have led to an increase in delinquent collections for the US Food and Drug Administration.

Program fees constituted the only charges that companies did not pay in a timely manner in fiscal year 2018, according...

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