The federal government is in a funding lapse, a formal way of saying Congress didn’t pass a budget, and the government has “shut down.” If you’re a company developing a new medicine or device, you might assume the FDA’s doors are completely closed—but that is a critical misconception. While a shutdown does create significant regulatory friction, the FDA has an independent source of funding that acts as a financial firewall, keeping key development work on track. Here is your essential guide to which submissions the FDA is still accepting and reviewing today.
The FDA’s ability to function is due to user fees paid by pharmaceutical and medical device companies to fund the review of their products (under acts like PDUFA). Crucially, the FDA had carryover user fee balances from the previous year. Think of it as an emergency savings account funded by the industry. The good news? The FDA can spend these savings to continue reviewing many applications and supporting staff, even when federal appropriations stop. This means: Review teams are still working on your existing applications (like NDAs and BLAs) that were already submitted and paid for.
The government shutdown does two things: it pauses the legal authority to collect new fees, but it does not stop the FDA from accepting documents that don’t require a fee. If your submission does NOT require a new user fee payment, the FDA can accept and review it right now.
| Submission Type (The “Go” List) | Why It’s Still Accepted & Reviewed |
| Investigational New Drug Applications (INDs) | INDs are the vital gateway to starting clinical trials and typically do not require an initial application fee. The FDA will continue to process these. |
| NDA and BLA Supplements | These are submissions for additional uses of an already-approved drug (like a new dosage or indication). They generally do not require a full new application fee. |
| Orphan Drug Applications | These products targeting rare diseases are often exempted from application fees. |
| Submissions with a Small Business Waiver | Companies that have qualified for a fee waiver (due to their size) can still have their New Drug Applications (NDAs) and Biologics License Applications (BLAs) accepted. |
For these non-fee-bearing submissions, continue to file them as planned. The FDA has confirmed its staff, funded by carryover user fees, will continue to review them until that carryover funding is exhausted. Your development clock can still tick forward.
There is a major exception; the FDA cannot legally accept submissions that require a brand-new user fee payment for the current fiscal year.
- New NDAs/BLAs (without a waiver): If your new drug application requires a fee, the FDA cannot process the payment, and therefore cannot officially “accept” the application. It will sit on hold.
- Annual User Fees: Do not attempt to pay your facility or annual product fees during the lapse; the system is legally blocked from accepting them.
While the political gridlock is frustrating, the FDA’s user fee structure is providing a critical buffer of continuity. Focus your regulatory efforts on INDs and Supplements, and hold your fee-bearing new applications. By doing so, you minimize the inevitable backlog and maximize your team’s progress during the shutdown.
