With a federal government shutdown now in effect, FDA has activated its FY 2026 contingency staffing plan. While essential safety activities and user fee–funded reviews will continue, many programs including new submissions and long-term initiatives are paused. Companies should anticipate disruptions in approval timelines, inspections, and policy development.
Activities That Will Continue
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User fee–funded reviews. FDA will continue reviewing pending drug, biologic, and device applications supported by carryover user fees. Guidance and regulation projects tied to these fees also proceed, as do requests to conduct clinical research. Oversight of tobacco products remains active.
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Critical safety functions. The agency will manage recalls, address shortages, monitor adverse events, respond to outbreaks, and perform for-cause inspections. Screening of imports, select surveillance inspections, and related laboratory testing will continue, supported by excepted staff.
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Staffing levels. Approximately 86% of FDA’s workforce will remain on duty: 66% funded through user fees and 19% designated “excepted” for safety and security functions.
Activities That Will Pause
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New submissions. FDA cannot accept new NDAs, ANDAs, BLAs, biosimilars, PMAs, De Novos, 510(k)s, or other fee-bearing applications. The clock on new submissions will not begin until funding resumes.
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Routine inspections. Most surveillance inspections will pause, with FDA prioritizing only those related to imminent public health threats.
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Food and animal programs. Pre-market reviews of novel food and animal feed ingredients are suspended. Longer-term initiatives including prevention strategies and policy development are halted.
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Compounding and unapproved drugs. Oversight will be limited to situations involving imminent threats to health and safety. Broader enforcement actions in these areas will pause.
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Regulatory science and policy projects. FDA’s forward-looking work including research projects, staff training, and innovation efforts will be delayed until appropriations are restored.
What Companies Should Do Now
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If your file is under review: Respond quickly to existing FDA requests and confirm meeting logistics, as responsiveness may be slower or nonexistent.
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If you are planning submissions: Adjust timelines to account for delays.
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For compliance and quality teams: Anticipate reduced FDA oversight, but note that for-cause inspections and enforcement actions will still proceed if safety issues arise.
"We have seen the shutdown already affect some FDA meetings. Given the uncertainty around its duration, companies should proactively develop strategies to navigate current and potential future limitations in FDA operations."
Nathan Downing, Managing Attorney, Gardner Law
