The start of October 2025 brought an unusual complication for the life sciences industry – a partial U.S. government shutdown that has significantly limited FDA operations. With much of the agency’s staff on furlough and access to key resources frozen, the FDA has announced that it will not accept or review new submissions requiring user fees until funding is restored.

While temporary, this pause poses serious implications for sponsors preparing regulatory submissions, managing ongoing reviews, or planning launches for late 2025 and early 2026.

What’s Affected

Under the Prescription Drug User Fee Act (PDUFA) and its related frameworks (GDUFA, BsUFA, MDUFA, etc.), the FDA collects user fees to fund much of its review activity. When a shutdown occurs, that user-fee funding becomes restricted which means:

• New fee-requiring submissions cannot be accepted.
  This includes INDs, NDAs, BLAs, ANDAs, and PMAs that require upfront payment before review begins.

• Ongoing reviews may continue temporarily using “carryover” funds, but these reserves are limited and will run out if the shutdown persists.

• Postmarket activities, such as inspections, labeling reviews, and compliance follow-ups, may also face delays as staff availability drops.

Certain operations, such as emergency product reviews or essential safety monitoring will continue, but the overall regulatory pipeline has slowed considerably.

Why This Matters

For companies working toward end-of-year milestones, even a short delay can have a cascading impact:

• Submission timing: Applications planned for Q4 may need to be postponed, compressing Q1 2026 timelines.

• Financing risk: Milestone-based funding tied to FDA acceptance or review starts could be delayed.

• Manufacturing and supply planning: Delays in approvals or feedback loops can ripple into CMO scheduling and batch release windows.

The last government shutdown in 2019 demonstrated how backlogs can persist long after agencies reopen. Sponsors that proactively plan for those ripple effects will be better positioned once normal operations resume.

What Sponsors Can Do Now

Even during the shutdown, teams can take meaningful steps to stay productive and reduce uncertainty:

1. Continue internal readiness work.
   Finalize validation packages, gap assessments, and risk management documentation so submissions can move quickly once the FDA reopens.

2. Engage proactively with third-party reviewers and CMOs.
   For combination products, ensure your device partners and testing facilities are aligned on any regulatory dependencies that might shift.

3. Update internal timelines.
   Build flexibility into program schedules and communicate potential delays to leadership, investors, and partners early.

4. Monitor FDA communications.
   The agency will update its official operations page with details on what services continue during the shutdown. Staying aligned with those updates helps sponsors adjust planning week by week.

How QSN Can Help

At Quality Solutions Now, we’ve navigated regulatory slowdowns before – whether caused by shutdowns, reorganization, or pandemic disruptions. Our team can help sponsors:

• Prioritize submission readiness, ensuring all CMC, quality, and combination product documentation is finalized.

• Evaluate risk exposure in ongoing programs and supply chains.

• Develop contingency plans for submission sequencing and resource allocation once reviews resume.

The current pause is temporary, but the strategic lessons it offers are long-lasting: flexibility, preparation, and clear communication are key to maintaining progress when the regulatory landscape shifts unexpectedly. Please contact us now to learn how we can help.