US FDA announces new priority vouchers for accelerated review times

The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening the FDA’s review time to 1-2 months following final drug application submissions.

Through the program, a new process for the FDA will convene experts from FDA offices for team-based review as opposed to the standard process of sending a drug’s application to different FDA offices and departments. “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,” stated US FDA Commissioner Marty Makary in a press announcement by the US FDA. “The ultimate goal is to bring more cures and meaningful treatments to the American public.”

A limited number of vouchers will be offered in the pilot year of the program, aimed at companies who align with US national priorities. The program may also offer these companies accelerated approval if the product meets applicable legal requirements for such steps. The CNPV program will also enhance communication with the drug sponsor throughout the review process. The FDA Commissioner’s office released specific criteria for companies looking to nab one of the limited vouchers, including addressing a health crisis in the US, delivering more innovative cures for the American people, addressing unmet public health needs, and increasing domestic drug manufacturing as a national security issue. Companies must qualify by submitting the chemistry, manufacturing, and controls portion of an application as well as draft labelling at least 60 days before a final application, and must be available for ongoing communication with the FDA. Potential companies can utilise the vouchers towards a specific investigational new drug or hold an undesignated voucher, which will allow the drug sponsor to use it for a new drug consistent with the CNPV’s objectives.

In the same statement by the FDA, Principal Deputy Commissioner Sara Brenner commented “This approach capitalises 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.”

Source:

FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests [Accessed June 18, 2025] https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests