In July 2025, FDA opened applications for the Commissioner’s National Priority Voucher (CNPV) pilot program to provide expedited review timelines for certain drug and biologics applications that address specified national health priorities.
Interested sponsors should become familiar with the program’s structure, purpose, eligibility criteria, application process, and review framework.
What Is the CNPV Program?
The Commissioner’s National Priority Voucher program is an FDA initiative that offers qualifying applicants a non-transferable voucher for a shortened review timeline of approximately one to two months after final application submission.
The voucher applies to a New Drug Application (NDA) or Biologics License Application (BLA) and includes enhanced communication opportunities with the FDA and the option for rolling review.
National Health Priorities That May Qualify for a Voucher
According to FDA, the program intends to address specific national health and security concerns. These include public health crises, reliance on foreign sources for critical drug components, and the need for more rapid development of certain therapies.
FDA has identified five categories of national priorities for the CNPV program:
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Addressing a health crisis in the United States
Examples include treatments for conditions with significant public health impact or those designated as emergencies.
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Delivering more innovative therapies
Including new therapeutic approaches or first-in-class products for conditions affecting U.S. populations.
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Addressing unmet public health needs
Examples include treatments for rare diseases or conditions with limited existing therapies.
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Increasing affordability
Products that may reduce overall treatment costs or lower barriers to patient access.
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Increasing domestic drug manufacturing capacity
Efforts that improve the security and resilience of the drug supply chain by increasing domestic production.
Once awarded, the voucher allows the applicant to submit an NDA or BLA for an accelerated review period. Vouchers cannot be transferred or sold.
CNVP Application Process
The program is open to developers of drugs and biologics that align with at least one of the listed national priorities. Applicants must submit a Statement of Interest through the FDA’s CNPV Program Submission Form.
- The statement is limited to 350 words.
- Applicants must identify the primary national priority addressed by their product.
- The submission may also indicate where enhanced FDA communication could facilitate development.
Each company may submit only one Statement of Interest describing how its platform, portfolio, or pipeline addresses a key national priority. The voucher may be tied to a specific product or be undesignated. In the case of an undesignated voucher, the applicant can decide later which qualifying NDA or BLA to apply it toward.
Because vouchers are awarded based on alignment with a national priority, any later NDA/BLA must still fall under that same priority area. FDA will confirm that the chosen NDA/BLA stems from the platform or development effort outlined in the original Statement of Interest.
The program uses a senior, multidisciplinary review model. Applications are evaluated by a team led by the Office of the Chief Medical and Scientific Officer. The process includes a pre-review stage and a discussion meeting before a decision is made on whether to award a voucher.
Applicants will be notified if additional information is needed for evaluation or upon approval.
Considerations for Potential Applicants
For the pilot phase, FDA is awarding just five vouchers total. The number of available vouchers granted may increase in the future. With the limited number of pilot program vouchers, companies should consider application readiness and clear eligibility. Other means of expediting approval may be more feasible (breakthrough therapy, fast track designation).
When evaluating whether to submit a Statement of Interest, companies may wish to consider:
- Whether the product clearly aligns with one or more of the national priority areas.
- Internal readiness to meet the condensed review timelines if a voucher is awarded.
- The ability to engage quickly and consistently with the FDA during the review process.
FDA may request additional information during its review of the Statement of Interest. Be prepared to respond promptly to any FDA inquiries regarding submission.
The FDA has established a CNPV email address for questions: [hidden email]. The submission system is currently accepting applications on a rolling basis. There is no publicly specified closing date for submissions.
For more information on other voucher programs and expedited approval pathways, please refer to Regulatory IP: Essentials of Lifecycle Management by Gregory J. Glover, MD JD, or refer to information posted on the Pharmaceutical Law Group website at www.pharmalawgrp.com. We look forward to seeing how the CNPV program develops over time.