Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), will depart the agency at the end of April after a turbulent tenure that included stricter review stances on rare‑disease and cell and gene therapies. Reports in STAT and other outlets detailed clashes between Prasad’s center and industry and patient groups over high‑profile drug rejections and altered guidance. The exit follows months of public disputes and a temporary firing-and-rehiring episode in 2025. Agency leadership has not named a permanent replacement, leaving a senior regulatory post in flux at a time when CBER oversees vaccines, gene therapies and blood products.