CTD Section 1.5.2 Report
Summary
Section Name:
Inactivation request
Section Code:
1.5.2
Module Number:
1
Description:
Protocol amendment document in which an IND sponsor notifies FDA that the clinical investigation is not active (note: yearly IND maintenance requirements are paused while the IND is inactive)
Submission Timing
Include in IND amendment (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources