The U.S. Food and Drug Administration (FDA) first announced its Commissioner’s National Priority Voucher (CNPV) pilot program on June 17, 2025. The goal of this program is to shorten the review time of new drug products and biologics to approximately 1-2 months following final drug application submission. The program is not expected to affect other expedited review programs but will incorporate some of their elements. According to the FDA, the voucher must be used within two years of receipt and can be used for a product at any stage in the drug development process.

The pilot program issued vouchers to companies aligned with U.S. national health priorities meeting at least one of the following requirements:

• 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.
• Increasing affordability.

In addition to these requirements, drug sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application and be available for ongoing communication with prompt responses to FDA inquiries during the review.

On October 16, 2025, the FDA announced the first nine voucher recipients, with additional CNPV recipients anticipated in the coming months. Selected products include:

While the review time is expected to be shortened to 1-2 months, the FDA notes that they may extend this window due to incomplete data or a complex review. A rapid review and approval seem most feasible for products with versions previously approved in the United States or in other countries. It will be interesting to see if and how quickly the remaining products are approved, and whether this will impact the time to approval of other products not in the program.