There are three types of priority review vouchers: tropical disease (created in 2007), rare pediatric (created in 2012), and medical countermeasure (created in 2016).
To be eligible for a tropical disease priority review voucher, a drug or biologic must satisfy the following criteria. Treat one of the following diseases:
- Blinding trachoma
- Brucellosis (FDA added in 2020)
- Buruli Ulcer
- Chagas (FDA added in 2015)
- Chikungunya virus disease (FDA added in 2018)
- Cryptococcal meningitis (FDA added in 2018)
- Filoviruses (including Ebola) (Congress added in 2014)
- Human African trypanosomiasis
- Lassa fever (FDA added in 2018)
- Lymphatic filariasis
- Material threat medical countermeasures (Congress added in 2016)
- Neurocysticercosis (FDA added in 2015)
- Opisthorchiasis (FDA added in 2020)
- Paragonimiasis (FDA added in 2020)
- Rabies (FDA added in 2018)
- Rare pediatric disease (Congress added in 2012)
- Soil transmitted helminthiasis
- Zika (Congress added in 2016)
Contain no active ingredient (including any ester or salt of the active ingredient) that has been approved in any other FDA application. Offer major advances in treatment, or provide treatment where no adequate therapy exists, thus earning priority review on its own merit. In other words, to win a bonus priority review, the treatment must first get its own priority review.
This web page is maintained by David Ridley, one of the authors of the priority review voucher program.