Commissioner's National Priority Voucher (CNPV) Pilot Program
Accelerated Drug Review for Companies Supporting U.S. National Interests
Program Overview
The FDA Commissioner's National Priority Voucher (CNPV) pilot program is being explored as a pathway to dramatically reduce review times for drug and biological product applications and manufacturing or efficacy supplements.
Announced in June 2025, this innovative program uses a collaborative tumor board-style review process to accelerate review and approval of products that align with one of five critical U.S. national health priorities:
- Public health crisis response - Products addressing urgent/emerging threats or significant population impact.
- Innovative breakthrough therapies - Transformative treatments with novel mechanisms that fundamentally change disease management.
- Large unmet medical needs - Therapies for conditions where existing treatments inadequately address patient outcomes.
- Onshoring and supply chain resilience - Onshoring drug development/manufacturing to strengthen U.S. domestic capacity, reduce foreign dependencies, and improve national security.
- Affordability - Approaches that improve overall value through reduced costs to the healthcare system or that enhance access to important products.
Vouchers may 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. Benefits of a voucher include enhanced communications and rolling review to help facilitate a shortened review time.
CNPV Compared To Other FDA Priority Review Programs
- Ultra-fast timeline – 1-2 months target vs. 6+ months
- Nontransferable vouchers
- Enhanced presubmission requests to facilitate expedited rolling review
- Multidisciplinary “tumor board-style” discussion between review team and senior agency leadership
The CNPV pilot is consistent with the FDA’s mission and maintains the FDA’s established safety and effectiveness approval standards, scientific rigor and regulatory compliance requirements. It 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.
Pre-market applications selected for the Commissioner's National Priority Voucher program 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.
All CNPV applications are reviewed by the appropriate review teams in the relevant FDA center. Review teams will continue to develop independent recommendations based upon their own scientific analysis and share these with a multidisciplinary tumor board-style panel (i.e., CNPV Review Council) for a collaborative discussion. The approval decision remains with the relevant product Center, using the Center’s normal processes.
Additional Information
Voucher Submission
About the Program
- Fact Sheet (.pdf, 229KB)
- FAQs: Commissioner’s National Priority Voucher Pilot Program
- Staff Manual Guide on Commissioner’s National Priority Voucher Review Council (.pdf, 153KB)
- CNPV Town Hall Program Overview (.pdf, 1.45MB)
- Press Announcement - FDA Announces Commissioner's National Priority Voucher (CNPV) Program
Voucher Awards
- FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
- FDA Awards Second Batch of National Priority Vouchers
- December 9, 2025: First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity | FDA
- December 15, 2025: FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results | FDA
- December 19, 2025: FDA Grants Two National Priority Vouchers | FDA