PDUFA Base-Rate Calculator
Pick the pathway and indication. Get the historical first-cycle approval rate, typical time to decision, and AdCom frequency. Built on published FDA approval analyses — approximate base rates for framing, not prediction.
Your PDUFA setup
Historical approval rate
—%
Select pathway + indication to see base rate.
Base rates are approximations from published FDA approval analyses. Every individual PDUFA is idiosyncratic — base rates frame, they don't predict.
About this tool
- Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Approximate — cross-check against recent CDER/CBER reports for specific indications.
- Informational, not investment advice.
- Pair with Clinical Readout Risk Scorer and Catalyst Scanner for a fuller picture.
- Methodology + interpretation on the AdCom interpretation blog post.