Vijay Kumar has announced he is stepping down as acting FDA acting director of the agency’s Office of Therapeutic Products overseeing cell and gene therapies within CBER. The exit follows a broader leadership shuffle inside the FDA’s biologics center and is expected to trigger an internal oversight transition. FDA said it remains committed to maintaining review timelines while preparing for the permanent director role through internal and external advertising. The change adds near-term uncertainty for sponsors navigating CBER policy and review priorities during ongoing cell and gene therapy workload.