An analysis found that despite extensive staff departures and leadership turnover at the FDA in 2025, reviewers largely met their user‑fee timelines for new drug reviews. Agency line staff adjusted workloads and prioritized incoming applications to maintain commitments under the Prescription Drug User Fee Act (PDUFA). The finding offers provisional reassurance to developers relying on US regulatory predictability after a tumultuous year of personnel changes. Still, analysts caution that maintaining timelines may have strained reviewers and could mask downstream impacts on advisory meetings, cross‑center interactions, or complex applications requiring specialized expertise. Companies should continue contingency planning for potential regulatory friction while engaging proactively with agency divisions to safeguard review quality.
Get the Daily Brief