CTD Section 1.7.1 Report
Summary
Section Name:
Fast track designation request
Section Code:
1.7.1
Module Number:
1
Description:
Formal request and supporting documentation for Fast Track designation, one of FDA's Expedited Programs
Submission Timing
Any submission prior to marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources