Can I submit a new NDA or BLA during a government shutdown?

No, new NDAs, BLAs, and supplements that require user fee payment cannot be accepted during a government shutdown. You must wait until appropriations are restored before submitting new applications.

What happens to my application that's already under FDA review during a shutdown?

Applications already in process may continue to be reviewed as long as funding via user fees or carryover budgets exists. However, staffing reductions and operational constraints typically slow the review process, making it difficult to meet original goal dates.

How long should I expect delays after a government shutdown?

Delays typically extend 2-3+ months beyond the shutdown duration due to backlogs and the time needed to restore normal operations. The actual impact depends on the shutdown length and when your submission was in the review cycle.

How a Government Shutdown Disrupts the FDA: Deadlines, Delays & What Sponsors Should Know

When Washington stops, your drug development timeline doesn't. A government shutdown isn't just political noise — for pharmaceutical sponsors, it's a regulatory earthquake that can derail years of planning, compress competitive advantages, and add millions to development costs. Here's what actually happens when the lights dim at the FDA, and how to protect your program when uncertainty becomes the only certainty.

When the lights dim at the FDA

A government shutdown isn't just political noise.

For drug developers, it can feel like someone hit the pause button — on your progress, your timelines, your momentum.

Suddenly, reviews stall. Meetings go silent. Uncertainty creeps in.

And all the careful planning you've done feels fragile.

The FDA doesn't announce these disruptions with fanfare. One day, operations are normal. The next, your regulatory contact stops responding, your submission window closes, and your carefully orchestrated timeline starts to unravel.

Let me walk you through exactly what shifts — and what you can do to protect your program.

What stops, what continues

First, the FDA doesn't shut down entirely.

Some functions must continue — especially those tied to public safety or funded by fees already collected. Activities critical to protecting public health, like monitoring adverse events and managing drug shortages, generally continue at reduced capacity.

But many critical areas get delayed or frozen. Here's the reality of what happens to your FDA interactions:

Activity	Impact During Shutdown
Accepting new applications	New NDAs, BLAs, supplements, and other submissions that require user fee payment cannot be accepted. Your filing is blocked until appropriations are restored.
Review of existing submissions	Those already in process may continue as long as funding via user fees or carryover exists. However, reduced staffing slows progress significantly.
FDA meetings / communications	Scheduled meetings may be canceled or postponed. Response times for information requests stretch indefinitely.
Routine inspections / audits	Generally paused unless deemed "for cause" or tied to immediate safety concerns.
Policy / guidance projects	Non-urgent policy work and regulatory science initiatives are completely halted.

The core projects you care about — new NDAs, 505(b)(2) applications, new submissions — are among the first to be blocked. The shutdown doesn't just slow your timeline; it can fundamentally alter your regulatory trajectory.

Why your deadlines shift

In a normal cycle, FDA reviews move forward on a predictable schedule: you pay user fees, your file is accepted, the clock starts, you respond to questions, and you get a decision within defined timeframes.

During a shutdown, that predictability evaporates. Here's the cascade of disruption:

1. No new filings

Your plan to submit can't launch until appropriations are restored. If you were targeting a specific submission window to align with market conditions or patent timelines, that opportunity may close permanently.

2. Delayed reviews

Even for files already in review, it's harder to hit goal dates because staffing is reduced and internal throughput is dramatically slowed. Review teams work with skeleton crews, if they work at all.

3. Meeting delays & silence

Scheduled FDA meetings may be postponed indefinitely. Response times for information requests stretch from days to weeks or months. The regulatory dialogue that keeps your program moving forward goes dark.

4. Backlog and stacking pressure

Once work resumes, there's a massive rush of piled-up submissions competing for limited reviewer attention. Your application joins a queue that wasn't there before, pushing timelines even further out.

If your plan assumed a 10-month review cycle, you may now face 12+ months, 14+ months, or an entirely unknown extension. The uncertainty itself becomes a strategic liability.

Critical Strategic Insight

A shutdown doesn't just delay your review — it can fundamentally change how the FDA evaluates your submission. Timing matters strategically. If your submission slides into a new fiscal year with different priorities, or if reviewer turnover occurs during the pause, your application may be viewed through an entirely different lens when operations resume.

The regulatory argument behind it

Why is this more than just a nuisance? Because a shutdown shifts regulatory risk — not the risk in your science, but the risk in how the FDA judges your science.

Consider these strategic impacts that often go overlooked:

Loss of regulatory momentum. Favorable signals from early meetings, fast-track designations, or breakthrough therapy status lose their momentum when the dialogue pauses. The FDA's institutional memory is good, but it's not perfect — especially if reviewer assignments change during the disruption.

Timing compression. Your strategic windows — patent exclusivity periods, market positioning advantages, optimal dosing studies — all get compressed. Delays don't just push your timeline; they reduce the commercial value of eventual approval.

Weakened negotiating position. When your submission finally resumes review after a shutdown, you're negotiating from a position of accumulated delay. The FDA knows you've already absorbed significant time costs, subtly shifting the power dynamic in any discussions about additional requirements.

Changing policy landscape. Extended shutdowns can mean your submission is reviewed under different guidance documents, priority frameworks, or even different leadership philosophies than when you started. What was acceptable regulatory precedent six months ago may not be today.

In other words, the shutdown doesn't just slow you — it changes the frame through which the FDA will view your dossier when they return.

Historical Shutdown Impact

35 days

Longest government shutdown (Dec 2018 - Jan 2019)

80%

FDA employees furloughed during shutdowns

3-6 mo

Typical delay recovery period post-shutdown

What you must do now

Don't wait and hope. A shutdown is predictable chaos — which means it's manageable with the right preparation. Use the pause strategically:

✓ Confirm where your file is

Is your application accepted? Is your meeting scheduled? Identify exactly what's on pause. Document all communication dates and response deadlines. Know your position in the queue before the lights go out.

✓ Respond fast to any pending questions

If the FDA has asked for information, provide it immediately — before the shutdown. When operations resume, responsiveness signals priority. Applications with pending responses often get pushed to the back of the restoration queue.

✓ Monitor your user fee balance

If your filing depends on a fee payment, ensure you're ready to act the moment funding resumes. Have payment authorization pre-approved. Don't lose days to internal finance processes when the window reopens.

✓ Review your risk buffer

Build slack into your timelines. Expect 2–3+ months of delay at minimum. Update stakeholder communications, investor projections, and partnership agreements to reflect extended timelines. Under-promise now; over-deliver later.

✓ Stay in touch with FDA contacts

Maintain relationships with regulatory project managers and division liaisons. Send a brief, professional note acknowledging the situation and expressing readiness to re-engage quickly. When they return, you want to be top-of-mind.

✓ Prioritize high-impact submission elements

Use the delay to strengthen your core arguments. Polish your executive summaries. Tighten your clinical data presentation. When review resumes, make it as easy as possible for reviewers to reach a positive conclusion quickly.

✓ Plan scenario alternatives

Model different shutdown duration scenarios. What happens to your program if the shutdown lasts two weeks? Two months? Six months? Have contingency plans ready for each scenario, including budget adjustments and stakeholder communications.

"In regulatory affairs, uncertainty is often more damaging than actual delays. A shutdown creates both. The teams that navigate it successfully are those who convert unknown timelines into strategic preparation time."
— Regulatory Strategy Principle

The takeaway

A government shutdown is a test — not of your molecule, but of your regulatory strategy.

It doesn't always break your project. But if you're unprepared, it can erode your schedule, compress your competitive advantage, and damage your credibility with stakeholders who expect you to navigate these predictable disruptions.

In times of regulatory pause, clarity and readiness matter most.

The shutdown creates a temporary vacuum. Smart sponsors fill that vacuum with preparation: tighter dossiers, clearer narratives, stronger data presentations. They use the forced pause to get operationally and strategically ahead.

When the FDA returns, the teams that have kept their regulatory narrative tight, their data presentation sharp, and their agency dialogue open will rebound strongest. They'll be first in line when the doors reopen. They'll have reviewers who remember their professionalism during the chaos.

Most importantly, they'll have used the uncertainty as a strategic advantage rather than letting it become a strategic liability.

Need to stress-test your timeline?

We help sponsors map safe paths through regulatory uncertainty. Let's build your shutdown-resilient strategy.

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Frequently Asked Questions

No, the FDA doesn't shut down entirely. Functions tied to public safety or funded by user fees already collected continue to operate. However, many critical areas experience delays, including acceptance of new drug applications requiring user fee payments, routine inspections, and policy guidance projects. Essential activities like adverse event monitoring and emergency responses typically continue at reduced capacity.

No, new NDAs, BLAs, and supplements that require user fee payment cannot be accepted during a government shutdown. The FDA cannot process user fee payments or formally accept new applications until appropriations are restored. You must wait until government funding resumes before submitting new applications. Plan accordingly if you're approaching a planned submission date.

Applications already in process may continue to be reviewed as long as funding via user fees or carryover budgets exists. However, substantially reduced staffing and operational constraints typically slow the review process significantly. It becomes much harder for the FDA to meet original goal dates. Expect communications to slow dramatically, scheduled meetings may be postponed, and information requests may go unanswered until operations normalize.

Delays typically extend 2-3+ months beyond the actual shutdown duration due to accumulated backlogs and the time needed to restore normal operations. The FDA must work through a queue of delayed submissions, postponed meetings, and suspended activities. The actual impact depends on how long the shutdown lasted, where your submission was in the review cycle, and how quickly the agency can staff back up to full capacity. Historically, it takes several months for review timelines to return to normal.

Yes, prudent planning includes building buffer time into development timelines to account for potential government shutdowns and other regulatory disruptions. Most experienced sponsors add 3-6 months of contingency time to account for unpredictable delays including shutdowns, additional FDA requests, and reviewer workload variations. This is especially important for 505(b)(2) programs where timing can significantly impact competitive positioning and patent strategies. Better to plan conservatively and deliver early than to scramble when inevitable disruptions occur.