The FDA faces significant staffing challenges with over 380 departures at the Center for Drug Evaluation and Research between January and June 2025, alongside minimal new hires. This attrition coincides with controversial regulatory moves, including FDA vaccines chief Vinay Prasad’s repeated override of agency reviewers to narrow Moderna’s COVID-19 vaccine approval in children and similar decisions affecting Sarepta’s Duchenne gene therapy. The agency’s new leadership priorities include stricter COVID vaccine approvals and enhanced safety warnings. Meanwhile, political and budget pressures, including ongoing proposed tariffs and funding cuts, contribute to operational uncertainty and regulatory project delays across pharmaceuticals and diagnostics sectors.