The U.S. Food and Drug Administration (FDA) is bracing against the impact of a potential federal government shutdown as congressional negotiations stall. The shutdown threatens to furlough or terminate up to 41% of Health and Human Services staff, compounding existing agency workforce disruptions this year. The FDA has dusted off contingency plans to maintain essential functions, but concerns about delays in new drug submissions, regulatory reviews, and enforcement activities are rising. High-level agency officials have communicated uncertainty and operational strain to staff, highlighting a fragile regulatory environment critical to biotech industry progress.