FY 2022 GDUFA Fee Rates

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration to assess and collect fees for Abbreviated New Drug Applications; Drug Master Files; Generic Drug Active Pharmaceutical Ingredient facilities, Finished Dosage Form facilities, and Contract Manufacturing Organization facilities; and Generic Drug Applicant Program User fees. Below are the FY 2022 (beginning October 1, 2022) fees.

Applications

Abbreviated New Drug Application (ANDA) $225,712

Drug Master File (DMF) $74,952

Facilities

Active Pharmaceutical Ingredient (API) Domestic $42,557

Active Pharmaceutical Ingredient (API) Foreign $57,557

Finished Dosage Form (FDF) Domestic $195,012

Finished Dosage Form (FDF) Foreign $210,012

Contract Manufacturing Organization (CMO) Domestic $65,004

Contract Manufacturing Organization (CMO) Foreign $80,004

GDUFA Program

Large size operation generic drug applicant 20+ ANDAs $1,536,856

Medium size operation generic drug applicant 6-19 ANDAs $614,742

Small business operation generic drug applicant 1-5 ANDAs $153,686

Federal Register July 28, 2021