FDA Launches New Priority Review Voucher Program Aligned with National Priorities

On June 17, 2025, the FDA launched the Commissioner's National Priority Voucher (CNPV) program to expedite drug reviews for biopharmas addressing U.S. national priorities12.

The CNPV aims to reduce drug review timelines from 10–12 months to as little as one or two months12.

Vouchers are limited, non-transferable, and remain valid even if a company changes ownership1.

Eligibility will be determined by the FDA Commissioner based on alignment with national priorities, which include addressing health crises, fostering innovative cures, tackling unmet public health needs, and boosting domestic drug manufacturing1.

Vouchers can be tied to a specific investigational drug or carry an 'undesignated' status, allowing use for any novel drug by the company1.

The program provides enhanced communication between the FDA and the sponsor throughout the process1.

Companies may still qualify for accelerated approval if their drug candidates meet the relevant criteria1.

Sources:

1. https://www.fiercebiotech.com/biotech/fda-launches-new-priority-review-voucher-biopharmas-align-national-priorities

2. https://www.biospace.com/policy/fda-rolls-out-commissioners-priority-voucher-program-to-speed-drug-reviews