Vijay Kumar, the acting FDA gene-therapy regulator overseeing cell and gene therapies within CBER’s Office of Therapeutic Products, is stepping down from the role after roughly a year in the position. FDA leadership said Karim Mikhail will assume direct oversight of the office during the transition, while the agency plans to advertise the permanent director opening. Kumar’s move follows broader CBER leadership churn in the past year, including departures and reversals of prior regulatory decisions under changing oversight. The timing may matter for biotech programs preparing submissions or already in review queues for advanced therapies. For companies, the near-term impact to watch is whether review timelines and agency expectations remain stable while the FDA transitions to a new permanent leader.