New agency hiring data show nearly 1,000 net departures from the FDA’s drug and biologics centers in the last quarter of fiscal 2025, marking an historic outflow that industry and policymakers say could stress review capacity and timelines. The departures overshadowed hundreds of recent hires and raised questions about institutional knowledge and review continuity. Agency officials and outside analysts warned that sustained staff losses could slow application reviews, complicate regulatory interactions and increase reliance on external consultants. Stakeholders urged attention to retention, targeted hiring and process improvements to blunt operational impact. Companies with near‑term filings may face less predictable timelines; the staffing trend could also intensify discussions around user fees, hiring incentives and structural reforms to preserve regulatory throughput.