FDA Hikes Fee for Fast-Tracking Tropical Disease Drugs in 2026
Published Date: 9/18/2025
Notice
Summary
The FDA is setting the fee for using a priority review voucher in fiscal year 2026. This affects companies with special drug applications for rare diseases, tropical diseases, or medical threats who want faster reviews. The fee is based on last year’s review costs, so get ready to pay the updated price when you submit your application next year!
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
FY2026 Priority Review Voucher Fee
If your company plans to use a Priority Review Voucher in fiscal year 2026, the FDA has set the fee you must pay when you submit a human drug or biological product application. The fee applies to applications using rare pediatric disease, material threat medical countermeasure (MCM), or tropical disease vouchers and is calculated from the difference between FDA's average costs to review priority versus non-priority applications in the previous fiscal year. The notice also outlines the payment procedures you must follow.
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