Agency is offering vouchers to some drug manufacturers to shorten review time for final drug applications
By Stephanie Brown HealthDay Reporter
WEDNESDAY, June 18, 2025 (HealthDay News) — On Tuesday, the U.S. Food and Drug Administration announced a new initiative to offer expedited reviews for new medicines, an initiative that will apply to drugs that administration officials determine promote “the health interests of Americans.”
The initiative, referred to as the Commissioner’s National Priority Voucher program, allows drug developers to participate in a novel FDA priority program. The program significantly shortens the FDA review time for a sponsor’s final drug application submission from approximately 10 to 12 months to one to two months.
This new process convenes experts from various FDA offices for a team-based review, which differs from the standard review system in which a drug application is sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists. This team will prereview all submitted information and then convene for a one-day “tumor board-style” meeting.
“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. The ultimate goal is to bring more cures and meaningful treatments to the American public,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. “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 one-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”
Specific criteria will be used to make the vouchers available to companies aligned with what the FDA considers national health priorities: confronting health crises in the United States; providing more innovative cures for the American people; fulfilling unmet public health needs; and expanding domestic drug manufacturing as a national security issue.
Qualifying drug manufacturers must submit the chemistry, manufacturing, and controls section of their application and the draft labeling at least 60 days prior to submitting their final application. They will also be expected to keep in communication and provide prompt responses to FDA inquiries during the review process.
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