FDA in Government Shutdown Mode: What Small & Start-Up Biotechs Should Do Now
- Sarah Dittmann
- Oct 3
- 3 min read
When one door closes, SWOT is here to help you find a new one.
This week, the U.S. federal government entered another shutdown. For small and start-up pharma and biotech companies, this means immediate implications for your submissions and regulatory timelines. With FDA in government shutdown mode, here's what’s happening now — and what you can do to stay on track.
What’s Continuing vs. What’s Paused with FDA in Government Shutdown Mode
With funding lapsed, the FDA is operating under its contingency plan:
✅ Continuing (at least for now):
Reviews of submissions already accepted with user fees paid (NDAs, BLAs, PMAs, 510(k)s).
Safety-critical work such as recalls, shortage monitoring, outbreak response.
Emergency inspections tied to imminent public health risks.
⏸️ Paused or Delayed:
New submissions requiring user-fees — the FDA cannot accept payments during the shutdown.
Most non-fee submissions (such as many INDs and certain supplements).
To be clear, you can still submit INDs, but review timelines may be delayed, and there’s potential for any scheduled meetings (including preIND) or routine correspondence to be postponed.
Routine inspections that are not linked to an immediate safety concern.
What You Should Do Right Now
1. Confirm Your Submission Status
Was it officially received? If you filed before the shutdown, check that the user-fee payment cleared and the FDA logged your application as “received and filed.”
Track ongoing reviews: If your submission is already in process, it’s likely still moving forward — but timelines may slip.
2. Hold New User-Fee Submissions
The FDA cannot accept new applications that require fees until the shutdown ends. Use this downtime to tighten your package so you’re ready to file the moment appropriations resume.
3. Reassess Your Timelines
Build in buffer time immediately. Even a short shutdown can push milestones by weeks; a longer one could stretch into months.
Update internal and investor communications to reflect revised expectations.
4. Monitor Carryover “Runway”
The FDA is currently relying on user-fee carryover funds. If the shutdown extends, those reserves will diminish and even active reviews could slow further.
5. Keep Safety-Related Work Front & Center
If your program involves adverse event reporting or urgent safety updates, continue submitting those promptly. Public-health priorities will still be acted on.
6. Communicate Proactively
Expect slower response times.
Keep correspondence concise and highlight any safety-critical elements.
Document delays — this may help later when FDA resumes normal operations.
How Long Will Delays Last?
Here’s what the impact could look like depending on shutdown duration:
1–2 weeks: Minor delays; mainly in new submissions and correspondence.
3–5 weeks: Moderate delays — expect 1–2 months of slippage in new starts and some slowdowns for reviews already in process.
6–10 weeks: Significant delays; 2–3+ month timeline impacts likely.
Over 10 weeks: Severe disruption. Backlog could take months to recover even after funding resumes.
How The Sugar Water Operations Team Can Help
Our team works with small and start-up biotechs to navigate uncertainty like this. We can:
Track and confirm your submission status.
Adjust project timelines and build shutdown buffers into your milestones.
Provide Regulatory Operations and eCTD publishing support so your submission is “day-one ready” once the shutdown ends.
Keep your SOPs, inspection readiness, and internal operations moving forward while FDA activities are slowed.
👉 Bottom line: The shutdown is here. If your submission is already accepted, it may keep moving — but expect delays. If you’re preparing a new submission, use this time wisely so you can file immediately once the shutdown ends.
