Industry groups and pharmaceutical companies are pushing the FDA to provide clearer guidance on when sponsors can rely on one pivotal trial plus confirmatory evidence for approval decisions. The request focuses on practical examples of acceptable “single-trial” pathways and the types of external or internal evidence that can substitute for a second study. The push reflects a growing tension between the cost and time required to run multiple registrational trials and the need for robust, decision-grade evidence. Companies want predictability so they can plan trials and development timelines with fewer regulatory surprises. If the FDA updates its approach, it could reshape how biotechs structure confirmatory studies—potentially increasing reliance on biomarkers, bridging data, registry evidence or historical controls where methodologically appropriate. For the biotech sector, clearer single-trial standards can materially affect capital efficiency, especially for smaller developers that need faster, less expensive registrational designs.