Navigating the National Priority Review Voucher: Challenges and Solutions 

In June 2025, the FDA introduced the National Priority Review Voucher (NPRV) program, an initiative designed to fast-track reviews for drugs deemed critical to U.S. national interests. Promising a one to two-month review window from final submission, this scheme significantly compresses the expected PDUFA timelines, which typically span six to ten months.  

The promise of acceleration is appealing, but experts at MMS understand that some of the challenges that already arise under other expedited review processes, like priority review and RTOR, are likely to be amplified with such a short review duration. As Dr. Amanda Beaster, Senior Director of Regulatory Strategy at MMS Holdings notes, “I would not want to go through such an expedited review without a strong data interpretation platform to support rapid interrogations of the data.” As Amanda explains it, the challenge isn’t just that the same number or more information requests (IRs) are issued in a shorter time frame, but that the turn around requested by the agency is also expedited, potentially seeking responses in hours, not days. This leaves very little time to program new outputs and draft data-driven responses. It’s also important to note that while sponsors can request extensions to respond to FDA queries, too many extensions may trigger a formal delay in the FDA’s timeline. With all of this in mind, MMS’ Datacise represents a valuable tool for sponsors and MMS’ regulatory teams participating in these expedited reviews. 

By ingesting SDTM datasets and visualizing them through a highly flexible and interactive interface, Datacise enables sponsors to explore safety and efficacy data in near real time in response to FDA requests. Whether it’s querying the frequencies of specific adverse events, evaluating different subgroups, or exploring the impact of other factors on case histories, the platform empowers teams to respond to FDA IRs at speed. “We’ve seen it in action,” says Kris Wenzel. “Once the data is in, navigating it becomes intuitive—even across large programs of studies.” This instant access to the data means that you have the answers to FDA questions before the TLFs are programmed, allowing for time to develop robust and accurate responses. 

Although the NPRV program is still in its infancy, it’s clear that sponsors hoping to benefit from its framework must be operationally ready. That means having data structured, accessible, and explorable from day one. 

As the FDA leans into the US’ national priorities, whether mental health, psychedelics, or future public health emergencies, tools like Datacise will be essential for sponsors navigating the expedited regulatory landscape. 

More broadly, MMS brings deep experience supporting trial sponsors with expedited approaches and a strong understanding of how the FDA operates behind the scenes. Our regulatory experts are available to consult with Sponsors on assessing potential eligibility and building operational readiness. Get in touch with our team to discuss how we can help you navigate NPRV or other accelerated programs.