Multiple reports this week documented deep unease inside the FDA and across drug developers as leadership turnover and high‑profile policy moves unsettle established regulatory norms. A BioCentury survey and staff reporting to STAT indicate concerns about politicization, leadership instability and abrupt policy memos issued without broad internal review. Agency insiders described internal churn and unpredictable decision processes that have eroded industry expectations for consistent, science‑based review timelines. Firms told investors they are recalibrating regulatory risk premiums and timelines for submissions. Observers warned this environment could slow approvals, complicate global filings where harmonized approaches are required, and add costs for parallel advisory or early engagement strategies. Stakeholders called for transparent timelines and reinforced scientific review pathways to restore predictability; meanwhile, sponsors are increasingly prioritizing regulator engagement and contingency planning in development programs.