CTD Section 1.1.8 Report
Summary
Section Name:
Form FDA 3792: Biosimilar User Fee Cover Sheet (BsUFA)
Section Code:
1.1.8
Module Number:
1
Description:
Form to accompany payment of BsUFA 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