Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), will leave the agency at the end of April after a contentious tenure characterized by stringent reviews and several high-profile drug rejections. Multiple outlets reported the departure and described how Prasad’s decisions on vaccines, gene and cell therapies—and his management moves—provoked industry and patient‑advocate pushback. Prasad’s leadership saw increased scrutiny of rare‑disease applications and a reworking of vaccine guidance; critics and supporters have both publicly debated whether his stricter posture reflects needed rigor or disruptive policy shifts. The FDA has not named a replacement; agency officials said the departure follows a planned leave-from-academia timeframe but noted the exit occurs amid ongoing regulatory tensions. Market and policy watchers flagged the move as a potential inflection point for CBER regulatory direction and stakeholder relations.