Vinay Prasad will depart the Food and Drug Administration at the end of April, concluding a turbulent tenure that saw heightened scrutiny of vaccine and rare-disease reviews. Reports from AP and other outlets detail a string of high-profile decisions—rejected submissions, reversals, and public disputes with industry and patient groups—that precipitated Prasad’s exit. FDA Commissioner Marty Makary notified staff of the departure, with no successor named. Prasad led the Center for Biologics Evaluation and Research (CBER), which oversees vaccines, blood products and gene therapies. His tenure included the initial rejection and subsequent acceptance of Moderna’s flu vaccine for review and contentious interactions with developers of rare-disease gene therapies. CBER’s role is to evaluate biologics safety and efficacy and to provide regulatory oversight on clinical-trial design and product approvals. Industry participants and patient advocates voiced concern over shifting guidance and perceived unpredictability in regulatory expectations under Prasad. The change in leadership will be closely watched by biotech companies developing vaccines, cell and gene therapies, as it may affect review timetables and the agency’s stance on evidence standards.