The FDA is grappling with internal leadership turbulence and regulatory controversies. Vinay Prasad, the recently departed head of the Center for Biologics Evaluation and Research (CBER), returned to his post at the agency following a politically charged ouster related to gene therapy decisions at Sarepta Therapeutics. Meanwhile, an internal report highlights concerns over FDA's use of impromptu expert panels lacking transparency and public vetting, raising questions about decision-making integrity. These developments occur alongside ongoing staffing challenges and calls for process normalization by FDA officials.