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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-06478 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
The FDA has officially set the review period for VYLOY, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind VYLOY, giving them a chance to extend their patent protection and potentially boost profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they must act by June 2 or September 30, 2026.
2026-06481 — Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
The FDA has set the official review period for HYMPAVZI, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind HYMPAVZI and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06480 — Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
The FDA has officially set the review period for EMRELIS, a medicine patent, so the patent owner can apply for extra protection time. If anyone thinks the dates are wrong, they have until June 2, 2026, to speak up. Also, people can challenge whether the patent owner was diligent during the review by September 30, 2026. This affects patent holders and could impact how long they keep exclusive rights to their product.
2026-06479 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
The FDA has set the official review period for ENFLONSIA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ENFLONSIA and anyone interested in patent rules. If you think the dates are wrong or want to challenge the company’s review speed, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06477 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
The FDA has officially set the review period for ENCELTO, a medicine patent, so the company can apply to extend its patent protection. This affects the drug maker by potentially giving them more time to exclusively sell ENCELTO, which can mean more money. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until June 2 or September 30, 2026, to speak up.
2026-06483 — Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
The FDA has officially set the review period for INJECTAFER, a drug patent up for extension. This means the company can apply to extend their patent protection, potentially keeping their exclusive rights longer and impacting competition and pricing. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by June 2 or September 30, 2026.
Previous / Next Documents
Previous: 2025-18074 — Sunshine Act Meeting Notice
The U.S. Commission on Civil Rights is holding a public meeting on September 19, 2025, to talk about Latino civil rights and appoint new state advisory members. Anyone interested can join in person in Washington, DC, or watch online for free. This meeting keeps the public in the loop and helps shape important civil rights work without any cost to attendees.
Next: 2025-18076 — Sunshine Act Meetings
The SEC and CFTC are teaming up for a public roundtable on September 29, 2025, to talk about making financial rules work better together. This meeting is open to everyone, but seats fill up fast, and you can watch online too. No big costs are involved, but if you want in-person, get there early and register!
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in