FDA Drug User Fees: GDUFA, OMUFA & PDUFA
Five years of verified fee data, compliance lifecycle maps, and plain-English explanations of who pays what — and when. Compiled from Federal Register notices by the regulatory team at FDABasics. We have helped clients in 50+ countries navigate FDA compliance, backed by over 30 years of regulatory experience and 5-star reviews on Trustpilot and Google.
Enjoy your complimentary FDA Drug User Fees Reference Guide. Contact us if you have questions or are ready to get started: info@fdabasics.com · (716) 775-0533
What's Inside
- FY2023–FY2027 fee tables for all three programs
- Who pays — and exactly when fees are triggered
- Consequences of non-payment & arrears lists
- Foreign facility surcharge guidance (GDUFA)
- GDUFA, OMUFA & PDUFA side-by-side comparison
- Cited Federal Register sources throughout
3
Fee programs covered in full
5
Fiscal years of verified fee data
30+
Years of FDA compliance experience
