The FDA named Katherine Szarama as acting director of the Center for Biologics Evaluation and Research (CBER) as the search for a permanent leader continues. Szarama will replace Vinay Prasad, who stepped aside after a contentious tenure marked by regulatory disputes affecting rare disease and vaccine oversight. In reporting on the transition, officials said a permanent CBER director is expected “in the coming weeks.” Szarama previously served as deputy at CBER and has a background spanning government research analysis roles and doctoral training at the Karolinska Institute. The appointment matters for biopharma stakeholders because CBER oversees vaccines, gene therapies, and parts of the U.S. biologics review workflow—areas where regulatory signaling can strongly affect development timelines.