The U.S. Food and Drug Administration signaled a policy shift toward allowing marketing authorizations based on a single adequate, well‑controlled trial as a default — a move agency leaders said could speed development and lower costs. FDA officials framed the change as an effort to streamline approvals for novel drugs, but analysts caution the policy’s real-world impact will depend on global regulatory norms and payer expectations. Commentators and industry experts note that while a single pivotal trial may accelerate U.S. approvals, international regulators and health technology assessors often demand additional evidence for reimbursement and access. The guidance therefore risks creating divergence between U.S. regulatory approvals and global market access strategies, complicating program design and commercial planning for sponsors. Clinical development teams and global regulatory leads are watching for clarifications and implementation details, particularly how the FDA will define adequacy and handle expectations around statistical robustness and confirmatory evidence.