The FDA’s Office of Therapeutic Products at CBER experienced a sudden shakeup as super office director Nicole Verdun, MD, and deputy Rachael Anatol, PhD, were placed on administrative leave. This comes shortly after Verdun’s leadership was praised for facilitating a groundbreaking CRISPR-based therapy curing a fatal disorder in a pediatric patient. The personnel changes have intensified concerns about regulatory continuity and expertise loss within the FDA’s cell and gene therapy oversight. The moves follow an agency leadership transition marked by earlier resignations and internal disputes, underscoring uncertainty amid a critical period for therapeutic approvals and biotech investor confidence.