Table 1—Priority Review Fee Schedule for FY 2025
Fee category Priority review fee rate for FY 2025 Application submitted with a tropical disease priority review voucher in addition to the normal PDUFA fee $2,482,446 Application submitted with a rare pediatric disease priority review voucher in addition to the normal PDUFA fee 2,482,446 Application submitted with a material threat MCM priority review voucher in addition to the normal PDUFA fee 2,482,446
Document Information
- Effective Date:
- 10/1/2024
- Published:
- 09/19/2024
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 2024-21433
- Dates:
- This rate is effective on October 1, 2024, and will remain in effect through September 30, 2025.
- Pages:
- 76846-76849 (4 pages)
- Docket Numbers:
- Docket No. FDA-2024-N-4246
- PDF File:
- 2024-21433.pdf