A BIOCentury report says the FDA is shifting from a punitive model to a reward-based “America First” PDUFA policy, changing incentives tied to where first-in-human trials are conducted. Under the reported reauthorization, overseas first-in-human trials would avoid a stated $10M penalty, while domestic first-in-human trials could see a $2M fee cut. The policy change is positioned as a structural incentive mechanism rather than a change in clinical evidence thresholds. Still, it can influence where companies site early studies—potentially affecting operational timelines, trial design logistics, and country-level clinical capacity. For biotech leaders, the update is a reminder that regulatory strategy is increasingly intertwined with location-based policy incentives in the CDx and biologics development pipeline.