Recent organizational changes within the U.S. FDA have led to the administrative leave and departure of top leadership in the Center for Biologics Evaluation and Research's Office of Therapeutic Products. These moves, reported amidst disagreements over the review of a Duchenne muscular dystrophy gene therapy and concerns about regulatory direction, have raised questions about the future management of cell and gene therapy approvals and policies. Stakeholders are closely watching how these developments will influence the regulatory landscape for advanced therapies.