Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs
The Premier Consulting Blog
AUGUST 8, 2024
As outlined in the table below, application fee rates, such as for a New Drug Application (NDA) or Biologics License Application (BLA), will increase by almost $300,000 in FY2025 (effective October 1, 2024). For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g.,
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