Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), will depart the agency at the end of April, FDA and news reports confirmed. Prasad’s tenure drew repeated controversy over high‑profile rejections of rare‑disease and cell‑and‑gene therapy applications and a reworking of vaccine guidance. The departure follows public clashes with industry and patient advocates; replacements have not been named. Agency leadership said the move aligns with Prasad’s earlier leave plans from academia, but industry sources note the exit occurs amid renewed scrutiny of CBER’s review approach and high‑stakes regulator‑industry tensions.