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an ultra-fast review timeline of 1-2 months target vs. 6-10 months the inability to sell or transfer vouchers to another party/companyan expiry of two years from voucher issuance
Companies may apply directly to the CNPV program.Internal FDA stakeholders (e.g., reviewers, review divisions, Center leadership) may nominate potential product candidates.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.
December 9, 2025: Augmentin XR had been previously approved but was no longer marketed and the product was discontinued. This approval reinstated the availability of supply for Augmentin XR.
February 26, 2026: Hernexeos was approved for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations as detected by an FDA-authorized test. The application was filed on January 13, 2026 and was approved 44 days later.
March 5, 2026: The FDA approved today the teclistamab and daratumumab in combination was approved for relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Approved 55 days from the filing (this application was also under real-time review so it is likely 55 days from the application being complete not when the submission was started).
CNPV Dashboard
Last updated 10 March 2026 - best viewed on desktop
Background
The Commissioner’s National Priority Voucher (CNPV) is a pilot program announced on June 17, 2025, by the U.S. Food and Drug Administration (FDA). The program offers a limited number of non-transferable vouchers to sponsors whose clinical assets align with key U.S. national health priorities. The CNPV pilot operates in addition to the existing Priority Review Voucher (PRV) program.
The pilot is intended to explore pathways to dramatically reduce review times for drug and biological product applications and manufacturing or efficacy supplements. These vouchers provide an expedited review (targeting 1–2 months following application acceptance) of the designated application instead of the typical 10–12 months or priority-review 6 months timeline, with enhanced interaction with FDA reviewers and a multi-disciplinary team-based review process.
CNPV compared to other PRVs
Key differences between the CNPV pilot program compared to the existing PRV programs include:
Please refer to the accompanying infographic for a detailed overview and feature comparison of the different priority voucher programs.
Voucher comparison graphic
CNPV selection criteria
Potential candidates for a voucher may be submitted via one of two pathways:
Products are selected that align with U.S. national health priorities, which are as follows:
Vouchers may be granted by the FDA for review of a company's specific drug/biological product application. When the pilot program was first announced, it was stated that vouchers may be issued for a specific drug/biologic product or as an undesignated voucher for the awarded company to select which product/indication to redeem it on. However, no undesignated vouchers have been issued, and revised CNPV documentation no longer references them, suggesting they are no longer part of the pilot program.
CNPVs awarded
Initially, five vouchers were expected to be issued under the pilot program. However, a total of 18 vouchers have been issued to date for specific products and indications. The tables below indicate the companies, products and product indications to which these vouchers have been awarded.
October 16, 2025
Company
Product
Indication
Pergoveris
Infertility
Tzield
Stage 3 Type 1 diabetes
cytisinicline
Nicotine vaping/e-cig addiction
DB-OTO
Deafness (OTOF-related)
Oxervate
Blindness (NAION)
daraxonrasib
Pancreatic cancer (PDAC)
bitopertin
Erythropoietic Protoporphyria
ketamine
General anesthesia
Augmentin XR
Bacterial infections
There are no rows in this table
November 06, 2025
Company
Product
Indication
Hernexeos
1L HER2 advanced NSCLC
Sirturo
Pediatric multi-drug resistant TB
Jemperli
dMMR/MSI-H advanced rectal cancer
Casgevy
Pediatric severe sickle cell disease
orforglipron
Obesity
Wegovy
7.2mg dose for obesity
There are no rows in this table
December 15, 2025
Company
Product
Indication
Tecvayli
With Darzalex for r/r multiple myeloma
There are no rows in this table
December 19, 2025
Company
Product
Indication
enlicitide
LDL-C reduction
sacituzumab tirumotecan
Triple-negative breast cancer
There are no rows in this table
CNPV review process
All CNPV applications are reviewed by the appropriate review teams in the relevant FDA center. The FDA is exploring the use of internally developed agentic AI-based tools to streamline specific components of the review process (e.g., filing checklist assessments) to expedite portions of the application process.
Review teams conduct independent scientific analyses and share their recommendations with a multidisciplinary “tumor board–style” panel known as the CNPV Review Council for collaborative discussion.
CNPV review timeline
Presubmission >
Filing Period >
Application Review
60 days
(may be longer if foreign inspections required)
14-21 days
30-60 days
This CNPV Review Council meeting will be scheduled to occur 1-2 weeks before the target action date.
There are no rows in this table
FDA review pathways
What happens during a CNPV review council meeting?
• The primary review team present to the Council and provide their preliminary scientific recommendation and supporting rationale on relevant portions of the application
• The Council provide a non-binding scientific recommendation determined by vote using pre-specified voting questions
• The Center Director consider the preliminary recommendation of the primary review team and the Council and convey a non-binding scientific recommendation to the review team
Decisions regarding drug approval remain within the FDA Centers.
For further information on the CNPV Review Council please refer to the FDA Staff Manual Guide:
FDA Staff Manual Guides (SMG), Volume III – General Administration. FDA Councils and Committees: Commissioner’s National Priority Voucher Review Council (Effective Date: January 15, 2026)
CNPV FDA town hall slides
The FDA held an internal town hall on February 3, 2025 on the CNPV program. The slides can be viewed in the embed below.
CNPV status tracker
CNPVs awarded and current status
Company
Product
Indication
Voucher
FDA filing/approval date
Pergoveris
Infertility
REDEEMED
Initiated filing submission
Tzield
Stage 3 Type 1 diabetes
REDEEMED
Decision delayed
cytisinicline
Nicotine vaping/e-cig addiction
unused
Est filing 2027
DB-OTO
Deafness (OTOF-related)
REDEEMED
Decision est H1 2026
Oxervate
Blindness (NAION)
unused
Unknown filing date
daraxonrasib
Pancreatic cancer (PDAC)
unused
Est filing 2026/2027
bitopertin
Erythropoietic Protoporphyria
REDEEMED
Complete Response Letter Feb 13th 2026
ketamine
General anesthesia
unused
Unknown filing date
Augmentin XR
Bacterial infections
REDEEMED
Approved Dec 10th 2025
Hernexeos
1L HER2 advanced NSCLC
REDEEMED
Approved Feb 26th 2026
Sirturo
Pediatric multi-drug resistant TB
unused
Est filing 2027
Jemperli
dMMR/MSI-H advanced rectal cancer
unused
Est filing 2026/2027
Casgevy
Pediatric severe sickle cell disease
unused
Filing H1 2026
orforglipron
Obesity
REDEEMED
Submission announced Dec 18
Wegovy
7.2mg dose for obesity
REDEEMED
Decision by est Mar 26, 2026
Tecvayli
With Darzalex for r/r multiple myeloma
REDEEMED
Approved Mar 5th 2026
enlicitide
LDL-C reduction
unused
Filing H1 2026
sacituzumab tirumotecan
Triple-negative breast cancer
unused
Unknown filing date
There are no rows in this table
CNPV approvals
Augmentin XR (amoxicillin-clavulanate potassium)
Hernexeos (zongertinib)
Tecvayli (teclistamab) + Darzalex (daratumumab hyaluronidase-fihj)
Sign up for updates!
Links:
U.S. Food and Drug Administration. Commissioner’s National Priority Voucher (CNPV) pilot program.
U.S. Food and Drug Administration. FDA to issue new Commissioner’s National Priority Vouchers to companies supporting U.S. national interests.
U.S. Food and Drug Administration. FDA awards first-ever national priority vouchers to nine sponsors.
U.S. Food and Drug Administration. FDA awards second batch of national priority vouchers.
U.S. Food and Drug Administration. FDA proactively awards national priority voucher based on strong Phase 3 study results.
U.S. Food and Drug Administration. FDA grants two national priority vouchers.
U.S. Food and Drug Administration. FAQs: Commissioner’s National Priority Voucher pilot program.
U.S. Food and Drug Administration. CDER, CBER, OCE Town Hall Pilot Program Overview.
U.S. Food and Drug Administration. First approval under Commissioner’s National Priority Voucher pilot program strengthens domestic antibiotic development.
U.S. Food and Drug Administration. FDA grants second approval under National Priority Voucher pilot program.
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