Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will depart the agency at the end of April, capping a turbulent term marked by high-profile reversals and industry pushback. Reports in STAT and other outlets detail multiple contested decisions under Prasad’s leadership, including stepped-up scrutiny of vaccines, gene therapies and rare‑disease submissions. Industry sources and agency statements show the exit follows public conflicts with drugmakers and patient groups over review standards and trial designs. FDA Commissioner Marty Makary notified staff of the departure; a replacement has not been named, leaving CBER leadership uncertain during a period of heightened industry regulatory sensitivity. The immediate operational consequence is potential disruption to ongoing reviews for vaccines, cell and gene therapies and other biologics that pass through CBER, as companies reassess regulatory interaction strategies with the agency.