FDA to hold public hearing on drug voucher pilot

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The FDA will hold a public hearing June 12 to gather feedback on its Commissioner’s National Priority Voucher pilot program.

The hearing will be held at the agency’s White Oak campus in Silver Spring, Md., with options to attend virtually, according to a March 20 news release. Stakeholders have until May 1 to request to speak. Written comments will be accepted through June 27.

The voucher program was launched in June 2025 to accelerate FDA review of drugs and biologics tied to national health priorities. To date, 18 products have been awarded vouchers and four have received approval, including two oncology therapies approved 44 and 55 days after filing.

The pilot offers a one- to two-month review timeline, enhanced presubmission engagement and a multidisciplinary review process led by the CNPV Review Council.

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