Vinay Prasad, M.D., has stepped down again as director of the FDA’s Center for Biologics Evaluation and Research (CBER), and Katherine Szarama, Ph.D., is now acting director while FDA searches for a permanent replacement. The change comes amid a highly scrutinized period for the center’s rare-disease and gene-therapy decisions. Szarama previously served as deputy since December, after a stint at ARPA-H. FDA Commissioner Marty Makary said a permanent CBER director is expected in the coming weeks, setting timing expectations for the agency’s biotherapeutics review leadership. For biotech developers, the shift matters because CBER oversight touches the review posture for vaccines, gene therapies, and blood products, including the CMC and trial-design expectations that can determine whether programs reach approval.