The US Food and Drug Administration has launched a new priority review voucher with the goal of reducing the agency’s drug review times to 1 to 2 months for certain novel drugs. Called the Commissioner’s National Priority Voucher (CNPV), the voucher would apply to drugs participating in a novel drug FDA priority program and that meet certain criteria, including consideration for being manufactured in the US.  

The new CNPV process seeks to reduce standard review times for qualifying drugs from 10 to 12 months to 1 to 2 months. It would achieve that by using experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor-board style” meeting. 

“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,” said FDA Commissioner Marty Makary M.D., M.P.H., in a June 17, 2025, statement in announcing the program. “… 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 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”   

The FDA plans to give a limited number of vouchers to companies in the first year of the program, which will begin in 2025, for drug candidates meeting the criteria that the drug is aligned with US national health priorities as identified by the FDA Commissioner. These priorities include, but are not limited to, the following: (1) addressing a health crisis in the US; (2) delivering more innovative cures; (3) addressing unmet public health needs; and (4) increasing domestic drug manufacturing as a national security issue. 

In addition to receiving the benefits of this program, FDA may also grant an accelerated approval, if the product for which the voucher is used, meets the applicable legal requirements for accelerated approval. The new review program will also include enhanced communication with the sponsor throughout the process.  

The new CNPV program does not affect pre-existing expedited review programs, such as fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation, The new CNPV program is separate and not mutually exclusive to these existing priority review programs and the Priority Review Voucher (PRV) programs already in place; these programs will continue as is. The CNPV program contains some of the elements and themes of the priority review programs and PRV programs. After a one-year pilot phase starting in 2025, FDA says it may increase the number of CNPVs it gives to companies. 

To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application. Sponsors must also be available for ongoing communication with prompt responses to FDA inquiries during the CNPV review. FDA says it 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. 

Vouchers can be directed by FDA toward  a specific investigational new drug of a company or be granted to a company as an undesignated voucher, which would allow a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives. These vouchers are non-transferrable, but they will remain valid through changes in company ownership. Also, the CNPV must be used within two years following receipt from FDA. 

The voucher can be applied to a product at any stage in development. If granted during the investigational new drug phase of a drug, the company will receive the CNPV’s enhanced communication benefits. Interim reviews throughout the process will benefit from enhanced communication and prompt responses. The program can be applied to drugs in any area of medicine. The program does not currently apply to devices or combination drug-device applications. 

To apply, FDA says it “will provide information in the near future on how companies seeking to apply can indicate their alignment with the FDA Commissioner’s criteria to meet national priorities.” 

Source: US Food and Drug Administration