CTD Section 1.1.9 Report
Summary
Section Name:
Form FDA 3794: Generic Drug User Fee Cover Sheet (GDUFA)
Section Code:
1.1.9
Module Number:
1
Description:
Form to accompany payment of GDUFA fees, does not apply to gene therapy INDs
Submission Timing
Required for biosimilars or generic drug applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources