The FDA said Katherine Szarama will take over as acting director of the Center for Biologics Evaluation and Research (CBER) following Vinay Prasad’s departure from the agency. HHS confirmed the move, and FDA Commissioner Marty Makary said a permanent director is expected to be announced in coming weeks. Prasad’s tenure was marked by repeated, high-profile disputes with industry groups over regulatory approaches for rare disease and gene-therapy decisions. The leadership shift raises attention around continuity versus change in how CBER evaluates evidence packages. For biotech stakeholders, CBER’s role in vaccines, gene therapies, and biologics places the acting directorship in the center of ongoing policy implementation and review priorities. The appointment also places Szarama—who previously served in research roles including at ARPA-H and Centers for Medicare and Medicaid Services—at the helm while the agency proceeds toward a longer-term staffing plan.