Generic Drug User Fees

Generic Drug User Fee Program

OMB: 0910-0727

IC ID: 204809

Documents and Forms

Document Name Document Type
GDUFA Cover Sheet.pdf Other-E-form Screenshot
GFI GDUFA II.pdf Other-Agency Guidance
FDA 3794 GDUFA Cover Sheet (e-form screenshot) Form FDA 3794 GDUFA Cover Sheet Screenshot.pdf Form
Form FDA 3794 GDUFA Cover Sheet Instructions.pdf userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp?legalsel=2&ref= Instruction
GDUFA Performance Goals and Program Enhancements 2023-2027.pdf Other-GDUFA Performance Goals