On June 17th 2025, the FDA today announced a Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans.
The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission. There will be a limited number of vouchers issued in the first year to companies that are aligned with the national health priorities of:
Addressing a health crisis in the U.S. Delivering more innovative cures for the American people. Addressing unmet public health needs. Increasing domestic drug manufacturing as a national security issue. Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives. The vouchers are not transferable but are retained if the company is acquired by another company and must be redeemed within 2 years.