CTD Section 1.5.3 Report
Summary
Section Name:
Reactivation request
Section Code:
1.5.3
Module Number:
1
Description:
Protocol amendment document in which an IND sponsor notifies FDA of their intent to resume clinical investigation after inactivation
Submission Timing
Include in IND amendment (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources