On the opening day of the 2025 Biotechnology Innovation Organization convention, FDA Commissioner Martin Makary announced a new pilot initiative granting selected companies access to a commissioner’s national priority voucher, facilitating review times shortened by one to two months. This accelerated pathway aims to improve the competitiveness of the U.S. biotech sector, addressing concerns about delays relative to other countries. The program represents a strategic effort to streamline regulatory processes for breakthrough therapies and rare disease treatments, supporting innovation and timely market access.