The FDA is undergoing significant leadership turnover with Jacqueline Corrigan-Curay, acting head of the Center for Drug Evaluation and Research (CDER), announcing her retirement in July. This follows other departures including Nicole Verdun, former director at the Center for Biologics Evaluation and Research (CBER). The exodus has raised uncertainty in the regulatory environment, especially for advanced therapies. Commissioner Martin Makary is reportedly considering appointing Karim Mikhail as a senior adviser to support these transitions amid ongoing regulatory policy shifts.