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Regulatory Focus™ > News Articles > 2019 > 9 > Fees for Redeeming Priority Review Vouchers Fall to All-Time Low in FY2020

Fees for Redeeming Priority Review Vouchers Fall to All-Time Low in FY2020

Posted 30 September 2019 | By Michael Mezher 

Fees for Redeeming Priority Review Vouchers Fall to All-Time Low in FY2020

The US Food and Drug Administration (FDA) on Friday announced the fees for using a priority review voucher (PRV) to speed the review of a new drug, biologic or medical countermeasure for vouchers redeemed in FY2020.
 
The agency's three PRV programs are meant to incentivize drug development in underserved areas, such as tropical diseases, rare pediatric diseases and medical countermeasures used in public emergencies. By using a PRV, a sponsor can receive a six-month priority review for a new drug application (NDA) or biologics license application (BLA) that otherwise would not qualify for one.
 
So far, FDA has issued more than 30 PRVs to drugmakers, including most recently its second voucher for a material threat medical countermeasure product to Bavarian Nordic for its Jynneos Smallpox and Monkeypox Vaccine.
 
The fee rate for all three programs, which is paid in addition to the normal Prescription Drug User Fee Act fees, is $2,167,116 for FY2020,  which is the lowest amount since FY2011, when the Food and Drug Administration Amendments Act created the fees for redeeming PRVs, and which is significantly less than the $2,457,140 fee in FY2019.
 
In three separate Federal Register notices, FDA explains how the fees are calculated as well as the procedures for paying the fees to the agency.
 
Federal Register Notices: Tropical Disease, Rare Pediatric Disease and Material Threat Medical Countermeasure Priority Review Voucher Fees

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