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FDA voucher program expedites high-need drug approvals

The FDA's new voucher program fast-tracks drug reviews to 1–2 months for therapies that address U.S. health crises, unmet needs or national security priorities.

Alivia Kaylor, MSc
By
Published: 17 Jun 2025

Today, the FDA introduced the Commissioner's National Priority Voucher program, designed to substantially reduce regulatory review timelines for drugs targeting specified U.S. public health priorities. The new program cuts the standard 10–12-month review period to just 1–2 months for eligible sponsors.

The FDA stated that the Commissioner's National Priority Voucher (CNPV) program will adopt a multidisciplinary, "tumor board-style" review process, convening expert teams across FDA offices for intensive, one-day review sessions rather than the traditional segmented review approach.

Sponsor eligibility

Initially limited to a small number of vouchers in its first year, the CNPV program is designed to support drug applications that align with the following national health priorities:

  • Addresses urgent U.S. health crises.
  • Provides innovative cures.
  • Meets significant unmet public health needs.
  • Strengthens domestic drug manufacturing as a matter of national security.

To participate, sponsors must provide key data elements, such as the chemistry, manufacturing and controls documentation and draft labeling, at least 60 days prior to the final NDA submission. Ongoing responsiveness to agency queries throughout the expedited review is also required.

"This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time," FDA Principal Deputy Commissioner Sara Brenner, M.D., M.P.H., said in the press release.

The FDA retains discretion in awarding vouchers and might grant them as either product-specific or undesignated. This allows the sponsor to apply the voucher to a drug candidate of their choice, provided it aligns with program goals.

The agency also reserves the right to extend the review period in cases of ambiguous trial results, incomplete submissions or unusually complex applications. If legal criteria are met, eligible drug candidates might also qualify for accelerated approval pathways, offering an additional route to market for promising therapies addressing urgent public health challenges.

Looking ahead

The launch of the CNPV program is part of the FDA's mission to modernize the drug review process. Earlier this month, the agency announced plans to roll out its internal generative AI tool, Elsa, across all FDA centers by June 30. Although Elsa has not been directly connected to the voucher program, its deployment reflects the agency's wider focus on improving operational efficiency and strengthening its digital infrastructure.

"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," FDA Commissioner Marty Makary, M.D., M.P.H., said. "The ultimate goal is to bring more cures and meaningful treatments to the American public."

As with other fast-track initiatives, the effectiveness of the CNPV program will depend on the agency's ability to maintain the integrity of its scientific review process while meeting significantly shorter timelines.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.

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