FDA Update

FDA Releases Generic Drug User Fee Amendments (GDUFA)

The FDA has released Fiscal Year 2026 user fee rates across multiple programs. While many of these updates apply broadly, the Generic Drug User Fee Amendments (GDUFA) directly impact facilities involved in generic drug manufacturing and submissions.

GDUFA FY 2026 Highlights:

These fees apply differently based on the facility type and whether it Is located in the United States or outside:

• API Facilities will pay $43,549.00 if located in the US and $58,549.00 if located outside the US.
• Finished Dosage Form (FDF) Facilities will pay $238,943.00 (U.S.) or $253,943.00 (non-US).
• Contract Manufacturing Organization (CMO) Facilities will pay $57,346.00 for US facilities and $72,346.00 for non-US facilities.

These rates take effect October 1, 2025, and timely payment is required to remain in compliance under GDUFA III.

Questions?

For more information on the FDA process for GDUFA please email us at: info@mdiconsultants.com and ref: GDUFA.