Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will leave the agency at the end of April, the agency confirmed. Prasad’s tenure was marked by a string of high‑profile, controversial decisions on vaccines, gene therapies and rare‑disease products that drew criticism from industry, patient groups and members of Congress. FDA Commissioner Marty Makary announced the departure in an internal email; a replacement has not been named. Prasad’s exit comes after disputes over review decisions that included an early rejection then reversal on Moderna’s mRNA flu vaccine application and a public clash with a small company over trial design for a Huntington’s gene therapy. The decisions prompted companies and advocacy groups to question the agency’s consistency on regulatory flexibility. The leadership change introduces near‑term uncertainty for review pathways affecting cell and gene therapies, vaccines and rare‑disease programs, given CBER’s expanded role on those products under Prasad’s oversight. Stakeholders will watch for interim management and whether the agency recalibrates guidance on trial designs and evidentiary standards.