This is a United States Food and Drug Administration (US FDA) voucher awarded to sponsors that develop medicines neglected tropical diseases, or rare paediatric diseases, or to use as medical countermeasures (e.g., medicines to mitigate harm from biological, chemical, radiological, or nuclear agents).
Few medicines are currently available to treat certain tropical diseases, rare paediatric diseases and to use as medical countermeasures due to their small market or potentially limited profitability. As incentives for the development of these products, the United States of America Congress created three PRV programs, which award the PRVs to sponsors that develop these products. The drug developers can redeem a voucher to speed up US FDA review of a future, potentially more profitable product, where when redeemed the developer’s application receives priority review from the US FDA with a targeted review time of 6 months, rather than the 10-month standard review. PRVs can also be sold to other developers.
Drug development: FDA’s priority review voucher programs (GAO, 2020)
Rare pediatric disease designation and priority review voucher programs (FDA, 2024)
Tropical disease priority review voucher program (FDA, 2024)
Regulatory explainer: everything you need to know about FDA’s priority review vouchers (RAPS, 2020)