Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Fee Rate for Using a Priority Review Voucher in Fiscal Year 2025, (Sep 20, 2024)

By WK Editorial Staff

The FDA is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2025.

The Federal Food, Drug, and Cosmetic Act (FDC Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FDC Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2025 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees. (Notice, 89 Fed. Reg. 76846 (Sept. 19, 2024)).

Dates. This rate is effective on October 1, 2024, and will remain in effect through September 30, 2025.

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