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FDA Priority Review Voucher Program.
A comprehensive source for PRV issuances, sales and redemptions. Designed for research, analytics and market intelligence.
What are FDA Priority Review Vouchers?
The FDA Priority Review Voucher programs incentivize drug development by rewarding companies that bring certain qualifying treatments to market.
Rare Pediatric Disease
Priority Review Voucher program, which incentivizes the development of treatments for serious or life-threatening pediatric conditions.
Awarded for treatments of serious or life-threatening rare diseases that primarily affect children under 18.
The term "rare pediatric disease" is defined as:
- a serious or life-threatening disease that primarily affect individuals aged from birth to 18 years.
- a rare disease or condition that affects less than 200,000 persons in the United States, or affects more than 200,000 in the United States and there is no expectation that the cost of developing a drug for such disease or condition will be recovered from sales in the United States.
Tropical Disease
Priority Review Voucher program, which incentivizes the development of drugs for neglected infectious diseases.
Awarded for prevention or treatment of certain tropical diseases that have had limited historic investment.
The term "tropical disease" is defined as:
- an infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations.
The legislation specifies the list of tropical diseases that qualify for a Priority Review Voucher.
Commissioner's National Priority Voucher
program, designed to reduce the FDA review time to 1-2 months for treatments aligned with U.S. national health priorities.
A pilot program rewarding treatments aligned with U.S national health priorities identified by FDA.
The ultimate goal of the program is ‘to bring more cures and meaningful treatments to the American public. Vouchers will be issued to companies that are aligned with the national health priorities of:
- Addressing a health crisis in the U.S.
- Delivering more innovative cures for the American people.
- Addressing unmet public health needs.
- Increasing domestic drug manufacturing as a national security issue.
Material Threat Medical Countermeasure
Priority Review Voucher program, which incentivizes development of countermeasures for biodefense and public health emergencies.
Awarded for prevention or treatment against high-risk threats such as chemical, biological, radiological, or nuclear agents.
The term "material threat medical countermeasure" is defined as a drug intended:
- to prevent, or treat harm from a biological, chemical, radiological, or nuclear agent identified as a material threat or
- to mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, or biological product against such agent.
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Vouchers issued across all FDA programmes
Voucher type issued
RPD, TD, or MTMC priority review vouchers
May be redeemed to obtain priority review for a product application that would otherwise not receive priority review. PRVs can also be sold or transferred between different companies.
Commissioner's National Priority Voucher
Reduces the timelines for FDA review from ~10-12 months to 1-2 months. These vouchers cannot be sold or transferred to another company and must be redeemed within 2 years.
Vouchers issued <12m
Redeemed - voucher was used by the original company the voucher was awarded to.
Sold - voucher was sold onwards, vouchers may have been subsequently redeemed.
Unknown - no public disclosure relating to this specific voucher.
Unused - voucher not redeemed.
Commissioner's National Priority Voucher (CNPV) tracker
PRVs sold over time (USD)
Only PRV transactions with a publicly disclosed price is shown. Where an exact date is not disclosed, the data point is marked at the last quarter of the reported time period. E.g if a sale/acquisition occurred in 2019 but no specified date given, this has been attributed to 2019 Q4.
Vouchers redeemed by year
Redeemed by application type
CNPVs redeemed
A priority review voucher was redeemed in Q4 2025 but it is currently unknown if this was redeemed for a new or supplementary application. This voucher is not accounted for in the chart above.
Redeemed by disease area
A priority review voucher was redeemed in Q4 2025 but it is currently unknown which product/indication this was redeemed for. This voucher is not accounted for in the chart above.
PRVWatch Pro
Full breakdown by therapeutic and disease area — available with PRVWatch Pro.
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