Federal Register #2026-15343

FDA Announces FY 2027 Generic and Prescription Drug User Fee Rates

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has published the official user fee rates for generic and prescription drug applications and facilities for fiscal year 2027. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEMs and Vendors: - FDA is the only entity mentioned; no commercial OEMs or vendors are referenced - Products/Services and Fee Categories: - Abbreviated New Drug Application (ANDA) Filing Fee: $375,684 per application - Drug Master File (DMF) Fee: $109,899 per file - Active Pharmaceutical Ingredient (API) Facility Fees: - Domestic: $39,680 annually - Foreign: $54,680 annually - Finished Dosage Form (FDF) Facility Fees: - Domestic: $230,033 annually - Foreign: $245,033 annually - Contract Manufacturing Organization (CMO) Facility Fees: - Domestic: $55,208 annually - Foreign: $70,208 annually - Generic Drug Applicant Program Fees (by size): - Large: $1,927,291 annually - Medium: $770,916 annually - Small: $192,729 annually - Prescription Drug User Fee Amendments (PDUFA VII) Fees: - Application with covered clinical data: $4,600,753 per application - Application without covered clinical data: $2,300,376 per application - Prescription Drug Program Fee: $416,857 per approved product annually - Unique/Notable Requirements: - These are regulatory user fees, not a procurement of goods or services - Fees apply to regulatory submissions and facility registrations for generic and prescription drugs - No part numbers or product SKUs beyond fee category identifiers - No commercial products or services are being purchased

Description

The Food and Drug Administration (FDA) announces the fiscal year 2027 fee rates under the Generic Drug User Fee Amendments of 2022 (GDUFA III). These fees apply to abbreviated new drug applications (ANDAs), drug master files (DMFs), and various generic drug facilities including active pharmaceutical ingredient (API), finished dosage form (FDF), and contract manufacturing organization (CMO) facilities. The fees also cover generic drug applicant program user fees. The fee rates are effective from October 1, 2026, through September 30, 2027.

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