CTD Section 1.7.2 Report
Summary
Section Name:
Fast track designation withdrawal request
Section Code:
1.7.2
Module Number:
1
Description:
Document in which a sponsor demonstrates to FDA that the criteria for Fast Track designation are no longer met and a request to rescind the designation
Submission Timing
IND amendment only (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources