The U.S. government shutdown has finally ended, and for the FDA, the relief is real. With Congress passing a funding bill covering the agency through September 30 of the next fiscal year, the agency now enjoys a measure of stability that reduces the risk of future funding lapses. But that doesn’t mean business as usual: backlog, staffing strain and timeline disruption remain real risks for sponsors and quality/regulatory teams.

During the shutdown the FDA operated on a contingency footing: mission-critical functions (such as safety monitoring, recalls, import screening, for-cause inspections) continued. Many routine activities, such as new user-fee submissions, many inspections, policy/guidance development, were delayed or halted altogether. For example, the agency publicly confirmed it could not accept new FY2026 user-fee-funded submissions until appropriations were restored.

Now that funding is back in place, what should life-sciences, devices and quality teams expect?

1. Review deadlines and submission timing will shift.

While previously filed submissions (those under user-fee programs and already accepted) can proceed, communication and responsiveness may lag as reviewers dig out from the backlog. For new submissions, expect a compressed window or “rush” of filings. This could translate to potential slower review clocks, increased workload on reviewers and elevated risk of missed deadlines or slower time-to-decision.

2. Inspection and surveillance activity will rebound, slowly.

Routine GMP/QMS inspections and regular surveillance inspections were deprioritized during the shutdown. As operations normalize, regulatory teams should anticipate a backlog of inspections, potential scheduling delays, and possibly stricter scrutiny as inspections catch up. It’s an opportune moment to review internal QMS readiness, remember that “just because things were delayed doesn’t mean risk is reduced.”

3. Submission readiness and procedural discipline matter more than ever.

The FDA recently published its internal checklists for filing reviews to increase transparency and help sponsors avoid “refuse to file” (RTF) setbacks. Given the heightened workload, even small administrative or completeness issues may no longer be tolerated. Sponsors will benefit from rigorous internal checks, early engagement with the FDA (for accepted interactions), and built-in buffers in project timelines.

4. Monitor for ripple effects.

Though the immediate shutdown has ended, the effects will echo. Delays in meeting scheduling, slower response to queries, potential review extensions and inspection bottlenecks will likely persist for weeks or months. For organizations planning launch-timing, investor updates, clinical-trial initiation or device clearance, the “new normal” may require more conservative assumptions.

Action Items for industry/regulatory/quality teams:

• Review any upcoming submissions or inspections and build in contingency time (e.g., extra 2–4 weeks).
• Audit internal submission packages for completeness and alignment with the FDA’s published filing checklists.
• Ensure inspection readiness now, and proactively address any open CAPAs, documentation gaps, vendor/QMS issues.
• Keep dialogue open with the FDA: confirm scheduled meetings or inspections, seek clarity on timelines and possible delays.
• Communicate internally (to project management, investors, business teams) that timeline risk has increased and should be incorporated into planning.

The end of the shutdown is a relief for regulatory operations, but it is far from a return to “normal.” For stakeholders working across drug/biologic/device lifecycles, it means more vigilance, more buffer time, and sharper submission discipline. If your organization is navigating delayed reviews, inspection backlogs, or time-sensitive regulatory and quality deliverables, QSN’s team of seasoned industry professionals are ready to support you. Contact us to keep your projects moving while the agency catches up.