Vinay Prasad stepped aside as director of the FDA’s Center for Biologics Evaluation and Research (CBER), with Katherine Szarama, Ph.D., taking over as acting director while regulators search for a permanent successor. The transition follows renewed scrutiny around CBER’s decisions affecting gene-therapy development. The article notes Szarama’s background spanning CBER deputy work, prior research at St. Jude Children’s Research Hospital, and earlier experience with ARPA-H, before returning to FDA leadership. FDA Commissioner Marty Makary said a new permanent CBER director is expected within weeks. For biotech developers, the leadership shift comes after a turbulent period for rare-disease and cell therapy reviews, when CBER’s approach to evidence requirements and trial designs became a central industry concern.