Vijay Kumar, the FDA’s acting director of CBER’s Office of Therapeutic Products overseeing cell and gene therapies, announced he is stepping down from the role. Kumar said the agency mutually decided not to renew his detail, and Acting CBER Director Karim Mikhail will assume direct oversight of the office during the transition. The leadership shift comes after a broader period of turnover in CBER’s management. In the meantime, the FDA signaled it remains committed to maintaining review timelines and will advertise the permanent director position both internally and externally. For developers in gene and cell therapy, the change is less about policy announcement and more about continuity and execution risk as review operations transition to new leadership structures.