FDA’s top gene-therapy regulator, Vijay Kumar, is stepping down from his role as acting director of the Office of Tissues and Gene Therapies within CBER, according to an email obtained by STAT. Kumar’s departure follows a broader CBER leadership shakeup and adds to an already turbulent year of turnover in the agency’s cell and gene therapy leadership. For biotech developers, the change lands as companies watch how FDA prioritizes review timelines, risk-benefit calibration, and oversight capacity for fast-moving gene therapy programs. The regulator’s transition could further intensify scrutiny of internal resourcing and decision throughput during active review cycles. The story matters most for developers with late-stage biologics in flight or newly submitted gene therapy dossiers, where continuity in senior review leadership can affect engagement cadence and internal alignment across review divisions.