The FDA has officially launched a new review voucher, the Commissioner’s National Priority Voucher (CNPV), an initiative to accelerate the review timeline for new drugs and biologics. The program promises to shorten FDA review time from the current 6–12 months (under PDUFA timelines) to as little as 1–2 months. Targeting products that align with U.S. national health priorities, the CNPV program is poised to reshape how life-saving therapies reach patients, though important questions remain.
Unlike traditional reviews that pass an application through multiple FDA offices, the CNPV introduces a “team-based” review approach modeled after the tumor board method used in cancer care. A multidisciplinary FDA team will conduct a one-day meeting to review submitted materials, allowing for faster, unified decision-making. This shift is designed to eliminate inefficiencies and streamline approvals, echoing successful elements from past initiatives like the Real-Time Oncology Review (RTOR) and STAR pilot programs.
The CNPV pilot program will launch with a limited number of vouchers in 2025. The FDA has yet to announce the exact number or how companies can apply, but eligibility criteria will focus on alignment with national priorities. These include addressing health crises, advancing innovative cures, meeting unmet public health needs, and increasing domestic drug manufacturing. While all criteria are relevant, U.S.-based manufacturing may become a key differentiator given national security considerations.
CNPVs can be issued as “product designated” (tied to a specific drug) or “product undesignated” (usable for any qualifying drug in the pipeline). The latter offers more flexibility, allowing companies to pivot if development hits obstacles. However, this flexibility carries risk: if a company uses the voucher prematurely and clinical trials later fail, it could lose a valuable opportunity for a more viable candidate.
To qualify for the accelerated timeline, companies must submit most of their application (other than the ongoing clinical trials), including their chemistry, manufacturing, and controls (CMC) section and draft labeling, at least 60 days before the final application. They must also maintain open, rapid communication with the FDA throughout the process. The FDA has reserved the right to extend the review window in cases of incomplete submissions, ambiguous trial results, or complex reviews, signaling a balance between speed and scientific rigor.
Interestingly, the CNPV can also be used during early drug development stages, such as the IND phase, offering benefits like enhanced FDA communication and guidance. However, it remains unclear whether the same review privileges apply at the marketing application stage if a voucher is used earlier. The vouchers are non-transferrable but remain valid through company ownership changes and must be used within two years. Unlike the “Priority Review Vouchers” that can be sold to other companies, the CNPV will likely add value directly to the company getting it, and would require aggressive development.
Although the CNPV builds on lessons from programs like RTOR—where reviews have taken as little as 11 days—there are key differences. Notably, CNPV vouchers may be used before clinical trials are complete, potentially without efficacy data in hand. This could limit the FDA’s ability to deliver on the 1–2 month review window in all cases.
As the FDA attempts to modernize and accelerate drug development, the CNPV program offers real promise. But with FDA workloads already high and standard review timelines often delayed, whether the agency can consistently meet its ambitious goals remains to be seen. The industry will be watching closely as this pilot phase unfolds.
