BRIEF—Non-fee FDA submissions update

The US Food and Drug Administration (FDA) on Friday posted an update to let industry know that the agency can still accept submissions for fiscal year 2026 that do not require a fee payment and for which FDA review work is covered by available carryover user fee funding.

For example, for Prescription Drug User Fee Act (PDUFA)-covered products, submissions that do not require payment of a user fee include INDs, NDA and BLA supplements, orphan drug applications, and NDAs and BLAs where the sponsor has obtained a small business waiver.

Such submissions can be accepted by FDA during the lapse period and the agency can review them using available carryover user fees to support this work, until such carryover funding is exhausted.