Regulatory Focus™ > News Articles > 2020 > 10 > FDA announces all-time low rates for FY2021 PRVs

FDA announces all-time low rates for FY2021 PRVs

Posted 05 October 2020 | By Kari Oakes 

FDA announces all-time low rates for FY2021 PRVs

The US Food and Drug Administration (FDA) has announced historic low rates for the fiscal year 2021 fees to use its three priority review voucher programs.
For the upcoming fiscal year, the rate to use a material threat medical countermeasure (MCM) priority review voucher (PRV) is an all-time low $1,360,879. The PRV rate is the same for the rare pediatric disease and rare tropical disease voucher programs, according to Federal Register announcements.
This figure is in addition to the required prescription drug user fee amendments fees for FY 2021, and it represents the agency’s estimate of the additional cost for the compressed 6-month review timeline earned by presentation of the PRV.
User fees fell again from the previous all-time lows of 2019, based on FDA calculating that its costs to complete the priority reviews also fell. (RELATED: Fees for redeeming priority review vouchers fall to all-time low in 2020, Regulatory Focus 30 September 2019)
Holders of PRVs may either use them or transfer them to another party. “The voucher may be transferred repeatedly until it ultimately is used for a human drug application submitted to FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the Public Health Service Act,” according to the Federal Review notice of the MCM PRV fees for 2021.
Medical Thread Medical Countermeasures PRV fee announcement
Rare Tropical Disease PRV fee announcement
Rare Pediatric Disease PRV fee announcement


© 2021 Regulatory Affairs Professionals Society.

Tags: FDA, US

Regulatory Focus newsletters

All the biggest regulatory news and happenings.