FDA Voucher Program Provides Shorter Drug Application Review Time

FDA announced on June 17, 2025 that it has created the Commissioner’s National Priority Voucher (CNPV) program to help shorten the review times for drug approvals. The program provides a voucher that drug developers can redeem so they may participate in a novel priority program that will shorten the final drug application submission review time from 10–12 months to one to two months. The program will begin in 2025 with a one-year pilot phase. The number of vouchers will be limited in the first year of the program to “companies aligned with US national priorities” (1,2).

Experts from FDA offices will meet for a “team-based review” as part of the new CNPV process, with a multidisciplinary team of physicians and scientists reviewing clinical information and pre-reviewing submitted information in a one-day “tumor board style” meeting.

Participants in the program may also be granted accelerated approval if applicable legal requirements are met. In addition, the program will offer enhanced communication between the agency and the sponsor.

To qualify for the program, applicants must meet the following criteria:

• must address a health crisis in the United States

• must deliver more innovative cures for the American people
• must address unmet public health needs
• must increase domestic drug manufacturing as a national security issue.

Applicants must submit the chemistry, manufacturing, and controls part of their application and the draft labeling at least 60 days before submitting their final application. Sponsors are expected to be available for prompt, ongoing communications with the agency during the CNPV review. “FDA reserves the right to extend the review window if the data or application components submitted are insufficient or incomplete, if the results of pivotal trial(s) are ambiguous, or if the review is particularly complex,” the agency stated in the press release.

FDA may direct vouchers to specific investigational new drugs or grant a voucher to a company as an undesignated voucher, which would allow the voucher to be used for a new drug at the sponsor company’s discretion. Vouchers, however, are non-transferrable to other companies but will remain valid through changes in company ownership. Vouchers must be used within two years of receipt (2).

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary in a press release (1). “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a one-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”

“This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time. We are confident this more efficient process can be achieved without cutting any corners on safety or scientific evaluation,” said FDA Principal Deputy Commissioner Sara Brenner.

FDA’s existing Priority Review Voucher (PRV) program will continue as is and is separate from the new CNPV. PRV will have a different timeline for review (2).

Reference

1. FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. Press Release. June 17, 2025. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests
2. FDA. FAQs: Commissioner’s National Priority Voucher Program. FDA.gov (accessed June 18, 2025). https://www.fda.gov/news-events/press-announcements/faqs-commissioners-national-priority-voucher-program