Commissioner's National Priority Voucher (CNPV) Pilot Program

Accelerated Drug Review for Companies Supporting U.S. National Interests

Program Overview

The Food and Drug Administration (FDA or Agency) is announcing the opportunity for prescription drug and biological product developers (“companies”) to participate in the FDA Commissioner's National Priority Voucher (CNPV) pilot program. The CNPV pilot program offers an unprecedented opportunity to reduce drug and biological product application or efficacy supplement (ES) review times from 10-12 months to just 1-2 months. Announced in June 2025, this innovative program uses a collaborative tumor board style review process to accelerate approvals for companies aligned with critical U.S. national health priorities.

Companies selected for the program will be issued a voucher entitling the company to benefits including enhanced communications and rolling review to allow for a shortened review time. The CNPV pilot program reflects the FDA's broader commitment to create more efficient approval processes and modernize regulatory frameworks for greater agility to meet emerging public health needs.

FDA’s authority for this program stems from its general authority to implement the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) consistent with its mission to promote and protect the public health, including with respect to review of applications submitted for approval for a drug under section 505 of the FDCA (21 U.S.C. § 355) or a biological product under section 351 of the PHSA (42 U.S.C. § 262).

We have outlined below the eligibility criteria, statement of interest requirements, selection criteria, and what companies can expect through program participation.

Key Program Benefits

Faster review times (10-12 months vs. 1-2 months)
Enhanced communication throughout the review process
Multidisciplinary team-based evaluation
Potential for accelerated approval if applicable requirements are met
Maintains FDA's rigorous safety and efficacy standards

Submit Your Statement of Interest

Background and Program Priorities

Today, approximately three-quarters of young Americans would not qualify for military service without a waiver, often on account of obesity and other health conditions. Additionally, the vast majority of the active pharmaceutical ingredients and drug components in Americans’ everyday medicines are supplied from China. These are two examples, among many others, reflecting severe threats to U.S. national security and the ability of Americans to live prosperous, healthy lives. FDA and the pharmaceutical industry must act with appropriate urgency to advance transformative products and secure our critical supply chains.

Program Priorities

The Commissioner's National Priority Voucher pilot program was designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans.

Specific priorities include:

Addressing a U.S. public health crisis. An example could include developing a universal flu vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential.
Delivering more innovative cures for the American people. The focus for this priority is transformative impact that far outstrips the threshold for breakthrough therapy designation. Examples could include creating a novel immunotherapy that reprograms the body's immune system to fight multiple diseases; or transforming mental health care through a novel treatment for PTSD.
Addressing a large unmet medical need. This includes a disease or condition that available therapies do not adequately treat, prevent, or diagnose, including drugs to treat rare diseases or address America’s chronic disease crisis.
Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency. Examples could include companies with new manufacturing establishments that shift manufacturing of essential medicines (such as generic sterile injectables) from foreign facilities to the U.S.; or a clinical trial that maintains robust U.S. enrollment to support generalizability for Americans against the U.S. standard of care.
Increasing affordability. This could include a company that lowers the U.S. price of a drug or reduces other downstream medical utilization to lower overall healthcare costs.

The program is distinguishable from programs that benefit only limited patient populations. The Commissioner's National Priority Voucher program will advance the broader America First agenda by accelerating cures and meaningful treatments with historic public health impact for Americans, especially including common chronic conditions and high prevalence diseases.

Key Program Features and Benefits

Faster review times (10-12 months vs. 1-2 months)
Enhanced communication throughout the review process
Multidisciplinary team-based evaluation
Potential for accelerated approval if applicable requirements are met
Maintains FDA's rigorous safety and efficacy standards

To accelerate review time from approximately 10-12 months to 1-2 months following submission of a drug or biological product application or efficacy supplement, the Commissioner's National Priority Voucher program submissions will be evaluated by a senior, multi-disciplinary review committee led by the FDA's Office of the Chief Medical and Scientific Officer, rather than a standard review system of an application being sent to numerous FDA offices staffed by discipline teams with primary and secondary reviewers juggling competing priorities. Participants must submit the chemistry, manufacturing, and controls (CMC) portion of their application (or efficacy supplement (ES)) and their proposed labeling at least 60 days before submitting their complete application/ES. The labeling must meet regulatory requirements (e.g., 21 CFR 201.56(a) and (d) and 21 CFR 201.57) and should be consistent with FDA labeling guidance recommendations, as appropriate (see the Prescribing Information Resources webpage.)

The Commissioner's National Priority Voucher program will include enhanced communication with companies throughout the process. Participants are expected to be available for ongoing communication with prompt responses to FDA inquiries. The FDA retains full discretion 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.

Pre-market applications for the Commissioner's National Priority Voucher program products will be subject to the same statutory and regulatory requirements for approval as applications that are not included in the program. In addition to receiving the benefits of this program, the Agency may also grant an accelerated approval if the product for which the voucher is used meets the applicable legal requirements.

For answers to commonly asked questions about this program, please visit our FAQs: Commissioner’s National Priority Voucher pilot program webpage where you can find detailed information and solutions to common queries.

Eligibility Criteria

Your company must demonstrate alignment with one or more of the Program Priorities above. Please note companies are limited to submitting one application or efficacy supplement. Vouchers can be granted by the FDA for review of a company’s specific drug/biological product application or be granted to a company as an undesignated voucher, allowing a company to use the voucher for review of a pre-market application for a drug/biological product at the company’s discretion subject to consistency with the program’s objectives.

Solicitation of Statements of Interest

Each drug review division within the FDA has been charged with nominating a product that they believe meets the stated national priority goals of the program. Sponsors can also apply and have their request reviewed by the designated review division.

Interested companies should submit a statement of interest to FDA via the Commissioner's National Priority Voucher (CNPV) Program Submission.

Following this general solicitation of statements of interest, FDA will select companies for possible acceptance into the pilot program. While discussion of the elements listed below is not a required for FDA to consider a statement of interest, a submission’s discussion of these factors is expected to aid FDA in its selection of pilot participants:

Company Information
- Company Name
- Primary Contact Name
- Contact Email
- Contact Phone
Which national health priority does your drug development program address? Select one. If more than one, select the primary priority. See Background section above for additional context.
- Addressing a U.S. public health crisis.
- Delivering more innovative cures for the American people.
- Addressing a large unmet medical need.
- Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency.
- Increasing affordability.
A brief description (350 words or fewer) of how your company’s drug development program aligns with the selected national health priority. Include information about the targeted disease or condition, the potential impact of your drug, the current stage of development (with clinical data highlights as relevant), any unique aspects of your approach that make it particularly relevant to the chosen priority, and any specific issue(s) for which you are seeking enhanced communications with FDA to facilitate program development. See Background above for additional context.

Submission and Selection

Companies that submit a statement of interest should be prepared to respond promptly to any FDA inquiries regarding their submission. Initially, FDA will reach out directly to companies it is considering, based on an evaluation of the statements of interest and nominations from review divisions. This approach allows the Agency to efficiently manage the review process and allocate its resources. In the interim, if you have any questions, we encourage you to visit FAQs: Commissioner's National Priority Voucher Pilot Program, which will be updated regularly as questions arise.

The Commissioner's National Priority Voucher pilot program submissions will be evaluated by a senior, multi-disciplinary review committee led by FDA’s Office of the Chief Medical and Scientific Officer. The council intends to select pilot participants based on the FDA Commissioner's national health priorities and application readiness (e.g., companies who demonstrate having the ability to move forward towards a marketing application). The council will select scientific and medical experts from relevant FDA offices and divisions for a team-based priority review.

For submissions showing initial promise, the FDA may contact companies directly to request an informational meeting with the company for additional information as part of the selection process. The Agency will focus on initial selections for the pilot program and may follow up with other companies that have expressed interest as appropriate over time.