Part 3 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series. Final installment in a three-part series on FDA user fee programs. Part 1 covered OMUFA, Part 2 covered MDUFA, and this...
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Part 3 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series.
Final installment in a three-part series on FDA user fee programs. Part 1 covered OMUFA, Part 2 covered MDUFA, and this article focuses on GDUFA.
The Abbreviated New Drug Application (ANDA) is only one part of GDUFA obligations.
GDUFA fees may also apply to:
Because fees are tied to portfolios, affiliates, and facility listings—not just submissions—GDUFA is one of FDA’s most data-dependent user fee programs.
GDUFA III runs through September 30, 2027.
Some fees increased (ANDA, DMF, applicant program), while most facility fees decreased. Each category must be evaluated independently for accurate forecasting.
The annual applicant fee is based on total approved ANDAs held by a company and its affiliates:
A single ANDA can shift a company from $192K to $770K+.
FDA also aggregates ANDAs across affiliates, meaning ownership changes or corporate restructuring can directly impact fees—even without new submissions.
Approved ANDAs remain in the fee calculation unless officially withdrawn. Companies should distinguish between:
Failure to reconcile these categories can lead to underestimating the applicant fee tier.
Facility fees are driven by FDA submission references, not current production status. A facility may still owe fees if it is:
Key classifications:
Stopping production does not automatically eliminate fee obligations—FDA records must be updated.
For FY 2027, foreign facilities pay $15,000 more than domestic counterparts across API, FDF, and CMO categories.
Global manufacturers should ensure facility location and classification data are accurate to avoid budget errors.
If the applicant program fee is not paid within 20 days:
GDUFA noncompliance can therefore affect both pipeline and marketed products.
Before FY 2027 begins:
GDUFA fees are driven by interconnected regulatory data—not isolated submissions.
A single overlooked ANDA, outdated affiliate record, or misclassified facility can significantly change annual obligations.
Accurate, centralized regulatory data is the strongest defense against unexpected fees and compliance risk.
Across OMUFA, MDUFA, and GDUFA, one theme is consistent: FDA user fees are data and workflow challenges as much as financial ones.
LexisNexis Life Sciences Solutions can help you align ANDA portfolios, affiliate relationships, and facility data; improve fee forecasting; coordinate payment workflows; and maintain audit-ready records. Whether your team manages GDUFA activities in-house using our solutions or relies on our experts to support the process, we can help reduce compliance surprises and regulatory risk.
Contact us to strengthen your GDUFA user fee management process.
Editorial note: Fee figures are current as of August 13, 2026. Companies should confirm FDA updates and assess applicability to their specific portfolios and facilities before payment decisions.