The FDA Commissioner’s National Priority Voucher (CNPV) Program -
What do we know?
Authors:
Dr Maria Beatrice Panico
Principal Medical Consultant
Erik Doevendans
Technical Head (NL) & Principal Consultant
Background
On the 17th of June 2025 the FDA Commissioner Marty Makary announced a new initiative aimed at enhancing the health interests of the United States (US) population. The Commissioner’s National Priority Voucher (CNPV) will be granted to US companies developing drugs that are:
Addressing a health crisis in the US
Delivering more innovative cures for the American people
Addressing unmet public health needs
Increasing domestic drug manufacturing as a national security issue.
The voucher can be applied to a product at any stage in development. One of the benefits of the voucher is the pre-submission phase. Drug developers will be allowed to pre-submit elements of their New Drug Application (NDA)/ Biologic License Application (BLA) package while still waiting for the final clinical trial results. In particular, recipients of a CNPV will be able to send in the chemistry, manufacturing and controls (CMC) portion as well as their draft labeling, at least 60 days before submitting the final data package. The FDA will expedite the review of the NDA/BLA application. The final decision will be taken in 1-2 months by a multidisciplinary team of experts rather than several FDA offices. In addition, applicants will have access to timely and frequent communications with the FDA in order to facilitate issue resolution.
A one-year pilot phase of the new program will be launched this year. The FDA will provide additional information about eligibility criteria, application procedure and number of CNPVs that can be granted in due course.
Other existing expedited review pathways, such as fast-track designation, breakthrough therapy designation and accelerated approval will not be affected.
Comparing CNPV with other FDA priority vouchers:
* sNDA / sBLA – supplemental NDA / supplemental BLA- Table modified from PRIORITY REVIEW VOUCHER WATCH
How can Scendea support?
At Scendea, our experts can help you navigate the opportunities and challenges associated with the new CNPV program. We can assess your eligibility, support you in submitting your application, and help you seek advice from the FDA.
Above all, our experts can assist you in identifying the right strategy for your unique development program.
Get in touch to learn more…