CTD Section 1.7.4 Report
Summary
Section Name:
Correspondence regarding fast track/rolling review
Section Code:
1.7.4
Module Number:
1
Description:
Summary document that contains any correspondance between the sponsor and the FDA regarding fast track designation or rolling review requests
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources