Vinay Prasad stepped aside as FDA’s Center for Biologics Evaluation and Research (CBER director), and Katherine Szarama will lead as acting director while the agency continues searching for a permanent replacement. The change follows Prasad’s turbulent tenure, including prominent regulatory disputes involving rare disease therapies and gene therapy decisions. HHS confirmed Szarama’s appointment, and FDA Commissioner Marty Makary said a new CBER director is expected “in the coming weeks.” The acting role keeps CBER leadership in the hands of a deputy-turned-interim chief as the organization navigates ongoing policy and review controversies. Industry attention remains on how CBER leadership may influence future review posture for biologics categories, including vaccines and gene therapies.