FDA Reports Millions In Unpaid GDUFA Fees
Agency figures reveal a shortfall of more than $20m last year
The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.
You may also be interested in...
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.
Generic Companies Race To Withdraw ANDAs
Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.
Biosimilar User Fee Collections Drop Well Below Estimates, But US FDA Not Worried
The agency hopes application volume increases, but warns the biosimilar user fee revenue will remain volatile.