FDA’s acting gene therapy regulator Vijay Kumar is stepping down from his role, according to an email obtained by STAT. The exit follows a broader leadership shakeup inside the agency’s Center for Biologics Evaluation and Research (CBER), where the cell and gene therapy office sits. Kumar had been promoted into the director role for the Office of Therapeutic Products after leadership changes that included earlier turnover at CBER. His departure adds another layer of instability for a regulatory area that has seen rapid growth in approvals and expanding scrutiny around manufacturing and clinical data.