FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Priority Review Voucher Fees Cut for Fiscal Year 2020

Oct. 10, 2019
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Effective Oct. 1, drugmakers will have to pay $2,167,116 million to redeem a priority review voucher for a newly approved drug or biologic for treatment of a rare pediatric disease, a tropical disease or for a medical countermeasure.

The cost of redeeming vouchers has dropped dramatically from over $5 million in 2012. The new fee represents an11.8 percent drop from the fiscal 2019 fee of $2.45 million.

The Congress created the PRV program in 2007, under which the FDA aims to review applications within six months.

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