The FDA named Katherine Szarama as acting director of the Center for Biologics Evaluation and Research (CBER), according to an HHS official cited by STAT. CBER regulates vaccines, gene therapies, and the blood supply. Szarama replaces Vinay Prasad, who left the agency Thursday after a tenure that included controversial decisions involving rare-disease drugs and vaccines. FDA Commissioner Marty Makary previously said Prasad would return to the University of California San Francisco. For developers in vaccine and gene-therapy categories, the leadership change lands as CBER continues to shape review expectations for complex biologics, including evidentiary standards and risk–benefit frameworks.