Despite Government Shutdown, Companies Still Plan to Submit FDA Applications

During the ongoing government shutdown, the FDA is not accepting any new drug or biologic applications, as the agency cannot collect the required industry user fees during the funding lapse13.

Major pharmaceutical companies including AbbVie, Amgen, Bristol Myers Squibb, Johnson & Johnson, and Pfizer had planned imminent submissions that are now delayed until appropriations are restored13.

The review of existing drug, biologic, and device applications continues if they are funded by previously collected user fees, and critical safety functions such as recalls and adverse event monitoring remain operational25.

Approximately 86% of FDA staff are retained during the shutdown—much higher than in past shutdowns—thanks to the availability of carryover user fees supporting ongoing work123.

Companies are expected to wait out the shutdown and plan to submit their applications as soon as the FDA resumes accepting new submissions, but delays in approval timelines are inevitable13.

Routine inspections, new policy development, certain regulatory science projects, and most new submissions—including NDAs, BLAs, ANDAs, biosimilars, PMAs, De Novos, and 510(k)s—are paused until funding is restored25.

The current situation marks the first such halt to new application acceptance in nearly seven years13.

Sources:

1. https://trial.medpath.com/news/8ba55ceadc5e286d/fda-halts-new-drug-application-acceptance-as-government-shutdown-begins

2. https://gardner.law/news/fda-during-government-shutdown

3. https://www.biospace.com/policy/fda-delays-likely-as-federal-government-hurtles-toward-shutdown

5. https://orthospinenews.com/2025/10/02/fda-halts-new-device-submissions-during-government-shutdown/