Key Takeaways
- FDA fast-tracks reviews for priority drugs: The new Commissioner’s National Priority Voucher (CNPV) program reduces review times from 10–12 months to as little as 1–2 months for qualifying applications.
- Multidisciplinary “tumor board” model improves efficiency: A single-day, expert team review aims to replace the fragmented traditional FDA review process.
- Program supports national health and security goals: Vouchers will prioritize drugs that address public health crises, unmet needs, or US-based manufacturing.
The FDA has introduced the Commissioner’s National Priority Voucher (CNPV) program, which is designed to dramatically reduce the time it takes to review certain drug applications that align with critical US health and security objectives, according to the agency. As part of this initiative, qualifying sponsors may be granted a voucher that enables the FDA to complete its review in as little as one to two months following final submission compared to the traditional 10–12-month review window.1
How Will the FDA’s New Voucher Program Fast-Track Critical Drug Approvals?
“Using a common-sense approach, 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,” said Marty Makary MD, MPH, FDA Commissioner, in a press release. “The ultimate goal is to bring more cures and meaningful treatments to the American public. As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”
A New Model for Faster, Collaborative Reviews
According to the agency, the CNPV reflects the FDA’s ongoing commitment to modernize its regulatory frameworks and accelerate access to transformative therapies without compromising safety or scientific rigor. Initially, a limited number of vouchers will be distributed to companies developing treatments that address urgent domestic health crises, unmet public health needs, or national security priorities, such as increasing US-based drug manufacturing. In qualifying cases, accelerated approval may also be granted under this program if statutory requirements are met.
Unlike the standard sequential review process, the CNPV will leverage a multidisciplinary “tumor board-style” model—commonly used in oncology—to expedite assessments. A designated team of FDA physicians and scientists will conduct a pre-review of the submitted information, followed by a one-day collaborative meeting to evaluate the data and reach a timely regulatory decision.
Program Requirements for Sponsors
To qualify, sponsors must submit essential components of their application—specifically the chemistry, manufacturing, and controls section and draft labeling—at least 60 days before filing the full application. They must also maintain consistent, responsive communication with FDA reviewers throughout the process.
Although the program is designed to streamline drug approvals, the FDA reserves the right to extend the review period if the submitted data are incomplete or ambiguous, or if the application presents a high degree of complexity. Vouchers may be tied to a specific investigational product or issued as general-use vouchers, allowing companies to apply them to a future drug aligned with the program’s goals.1
Global and Domestic Regulatory Context
The move comes as China revealed its own plans to cut down clinical review times. On Monday, the country’s National Medical Products Administration (NMPA) announced a proposal to decrease its review period from 60 days to 30 days. The NMPA has requested that any feedback from pharma companies or individuals be submitted by July 16, 2025.2
Domestically, the launch of the CNPV program follows broader federal workforce changes. In February, President Trump ordered the dismissal of all probationary federal employees, including at the FDA. The cuts disproportionately impacted those involved in research and medical device evaluation, according to former officials from the NIH, CMS, FDA, CDC, and other agencies.3
Communication and Scientific Standards Remain Key
“This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time,” said Sara Brenner, MD, MPH, Principal Deputy Commissioner, FDA, in the press release. “We are confident this more efficient process can be achieved without cutting any corners on safety or scientific evaluation
References
- FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. FDA. June 17, 2025. Accessed June 18, 2025. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests
- The General Office of the National Medical Products Administration publicly solicits opinions on the 'Announcement on Matters Related to Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (Draft for Public Comment)'. NMPA.gov. June 16, 2025. Accessed June 18, 2025. https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20250616142133128.html
- Former Health Agency Heads React to Federal Layoffs at NIH, CDC, and FDA. PharmExec. February 19, 2025. Accessed June 18, 2025. https://www.pharmexec.com/view/former-health-agency-heads-federal-layoffs-nih-cdc-fda
