The FDA moved to change leadership of its biologics oversight structure, naming Katherine Szarama as acting director of the Center for Biologics Evaluation and Research (CBER), which regulates vaccines, gene therapies and the blood supply. The appointment follows the departure of Vinay Prasad, who had a high-profile, controversial tenure tied to rare-disease product decisions. At the same time, US policymakers signaled tighter scrutiny of clinical evidence from abroad. A House spending committee reportedly called for banning drugmakers from using China trial data in future FDA drug applications, adding pressure on how sponsors structure global development programs and submissions. Separately, the FDA previewed an operational shift toward faster data handling, with plans to pilot “real-time” clinical trials using accumulated trial data streams, starting with oncology studies from Amgen and AstraZeneca. The moves collectively point to an FDA that is both governance-focused and attempting to compress development-to-decision timelines.