The Food and Drug Administration has placed the director and deputy of its cell and gene therapy office on administrative leave, escorting both out of the agency. This sudden leadership departure, coming amidst ongoing regulatory realignments, has drawn deep disappointment from the regenerative medicine field. Stakeholders express concern over the uncertainty introduced at a critical juncture when innovative therapies are transitioning rapidly through developmental pipelines. The shakeup raises questions about continuity in regulatory oversight in an area pivotal to cutting-edge biotechnologies targeting rare and complex diseases.