FDA Awards Two National Priority Review Vouchers; Agency Signals Accelerated Focus on Critical Medical Needs

Silver Spring, Maryland; December 20th, 2025

The U.S. Food and Drug Administration announced that it has granted two National Priority Review Vouchers, a regulatory action that allows qualifying drug developers to receive expedited review for future medical products addressing serious or life-threatening conditions.

According to the FDA’s official release, the vouchers were awarded under existing statutory authority designed to encourage the development of treatments for conditions that present significant public health challenges. A Priority Review Voucher enables its holder to request an accelerated FDA review for a subsequent drug application, shortening the standard review timeline and potentially bringing critical therapies to patients more quickly.

The FDA stated that these vouchers are not granted automatically; they are issued only when a sponsor meets strict eligibility criteria tied to innovation, unmet medical need, and demonstrated public health value. In awarding the two vouchers, the agency emphasized that the program remains a targeted incentive rather than a blanket acceleration mechanism, preserving regulatory rigor while promoting medical advancement.

The agency also reiterated that the granting of a voucher does not guarantee approval of any future product. All drugs submitted under a priority review request must still meet the FDA’s standards for safety, efficacy, and manufacturing quality. The voucher merely adjusts the review timeline, not the evidentiary requirements.

National Priority Review Vouchers have become a key policy tool for encouraging investment in areas such as rare diseases, infectious threats, and other conditions that may not otherwise attract sufficient private-sector development. By reducing regulatory uncertainty and time-to-market, the program seeks to align public health priorities with research and development incentives.

The FDA’s announcement reflects a continued emphasis on accelerating access to treatments where delays could have serious consequences, while maintaining the agency’s core responsibility to protect patient safety. The issuance of two vouchers signals that the agency views these qualifying developments as meeting the high threshold required for national priority consideration.

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Sources

Primary First-Hand Sources

• U.S. FOOD AND DRUG ADMINISTRATION, FDA News Release, “FDA Grants Two National Priority Review Vouchers.”