Editor’s Note from 2Firsts:
Although the FDA’s latest initiative is targeted at pharmaceuticals, it clearly signals that—when national interests are at stake—the agency is fully capable of breaking with existing procedures to establish a more efficient product approval framework, enabling faster responses to market needs.
Whether this mechanism will be extended to tobacco products remains uncertain. However, one thing is clear: the FDA now has both the authority and precedent to reform product approval pathways. As for changes to the PMTA process, what remains are questions of timing and technical details.
[By 2Firsts]On June 17, 2025 (local time), the U.S. Food and Drug Administration (FDA) announced the launch of the Commissioner’s National Priority Voucher (CNPV) program, a new initiative to accelerate the review process for drugs that align with U.S. national priorities. Drug sponsors that receive a CNPV may reduce their FDA review timeline from approximately 10–12 months to 1–2 months following final drug application submission.
According to the FDA, the new CNPV program introduces a team-based review approach. Rather than sending applications to multiple FDA offices for separate evaluations, the program assembles a multidisciplinary team of FDA physicians and scientists to pre-review submitted materials and then conduct a 1-day “tumor board style” meeting to evaluate the application collectively. This differs significantly from the agency’s traditional sequential review system.
FDA Commissioner Marty Makary, M.D., M.P.H., stated:
“The national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public.”
In the program’s first year, the FDA plans to issue a limited number of vouchers to companies aligned with U.S. national priorities. As outlined in the official announcement, vouchers will be prioritized for companies addressing the following:
● A health crisis in the United States;
● Delivery of more innovative cures for the American people;
● Unmet public health needs;
● Increased domestic drug manufacturing as a national security issue.
In addition to the benefits of priority review, accelerated approval may also be granted if the product meets the legal criteria for such designation.
To be eligible, sponsors must submit the chemistry, manufacturing, and controls (CMC) section of the application and draft labeling at least 60 days prior to final application submission. Sponsors must also be available for real-time communication and respond promptly to FDA inquiries during the CNPV review. The FDA reserves the right to extend the review timeline if submitted data are insufficient, ambiguous, or if the application is particularly complex.
CNPVs may be issued either for a specific investigational new drug or as an undesignated voucher, allowing the sponsor to apply it to any drug of their choosing, consistent with program objectives.
FDA Principal Deputy Commissioner Sara Brenner, M.D., M.P.H., commented:
“This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time. We are confident this more efficient process can be achieved without cutting any corners on safety or scientific evaluation.”
According to the agency, the CNPV initiative reflects FDA’s broader commitment to build more efficient approval pathways and modernize regulatory frameworks to better respond to emerging public health needs with greater agility.
📎 For the full FDA announcement, please click here. Official information shall prevail.
