Adapting to an Expedited Review Process
A new priority review program, unveiled by the FDA with the potential to dramatically reduce the regulatory review process for drug applications, will require increased agility, responsiveness, and readiness from CDMOs with less room for error.
In June 2025, the FDA launched its national priority review program — the Commissioner’s National Priority Voucher (CNPV) program — which is aimed at significantly accelerating the regulatory review process for drug products to a mere 1–2 months (1). Through this scheme, drug developers can start their submission process prior to completing a clinical trial, reducing inefficiencies in the review process.
“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,” confirmed FDA Commissioner Marty Makary M.D., M.P.H, in a press release (1). “The ultimate goal is to bring more cures and meaningful treatments to the American public.”
The program is set to start in 2025 — at the time of writing a precise date had not been confirmed — with a limited number of vouchers being offered during the pilot phase, which will last for a period of 12 months. After the initial pilot phase, the agency may decide to increase the number of vouchers it gives out to companies (2).
When deciding upon which companies should receive the vouchers, the FDA Commissioner will consider certain criteria that are aligned with national health priorities. These criteria include addressing a health crisis in the U.S., delivering more innovative cures for American citizens, addressing unmet public health needs, and increasing domestic drug manufacturing as a national security issue (1).
FDA has specified that sponsor companies are required to submit the chemistry, manufacturing, and controls (CMC) portion of their application and the draft labeling at least 60 days before submission of the final application to qualify for the program. Additionally, the agency has stipulated that sponsors must be available for ongoing communication, promptly responding to any inquiry from the FDA during the CNPV review.
“This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time,” added Principal Deputy FDA Commissioner Sara Brenner, M.D., M.P.H., in a press release (1). “We are confident this more efficient process can be achieved without cutting any corners on safety or scientific evaluation.”
Given the potential of this program to dramatically reduce drug review times, CDMOs will need to be flexible so that they can adjust to the compressed timeline. Responsiveness will also be paramount, as failing to respond to any FDA inquiry quickly enough could lead to delays in the review, mitigating the benefits of the accelerated procedure.
Therefore, it is clear that early-stage readiness and data quality will be critical for success with the CNPV program. Ultimately, CDMOs will need to ensure they have robust manufacturing processes in place and can quickly generate high-quality, audit-ready CMC data, with advanced technologies helping them to do so. In the end, the CDMOs that adapt to offer the required services to support such accelerated development will gain a competitive edge.
References
FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. Press Release, June 17, 2025.
FDA. FAQs: Commissioner’s National Priority Voucher Program. Press Release, July 1, 2025.