Everything's Special At US FDA: Priority NDA/BLA Filings Surge
The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.
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Sponsors will pay 12% less to redeem a voucher in FY 2020, which is charged on top of the traditional PDUFA user fee.
The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.
US FDA met more biosimilar user fee program meeting performance goals in FY 2018 compared to prior year but still fell short in scheduling for three of five types of meetings. Office of New Drugs reorganization, once completed, should address some logistical scheduling issues.