Katherine Szarama was named acting director of the FDA’s Center for Biologics Evaluation and Research (CBER), overseeing regulation for vaccines, gene therapies, and the blood supply. The appointment follows the departure of Vinay Prasad from the agency after a tenure described as tumultuous, including high-profile controversies around rare disease drug and vaccine decisions. The move places new leadership at CBER at a time when regulators are facing intense scrutiny over evidentiary thresholds, data integrity, and how complex biologic platforms—gene therapies in particular—are evaluated. For biopharma teams, leadership transitions at CBER can affect the tone of review management, including how additional data requests are handled and how pivotal programs are framed for future pathways.