FDA-TRACK: Prescription Drug User Fee Act Historical Performance - Procedural Notifications and Responses
Download PDUFA Historical Performance: Procedural Notifications and Responses Dataset
Footnotes:
- * Performance is currently preliminary due to pending submissions.
- ** New Performance Goal for PDUFA VII with performance tracking beginning in FY23 (see Changes for this Goal, page 35 for Human Factors Protocol to INDs and pages 12-13 for Priority and Standard NME NDA and Original BLA PMRs).