CTD Section 1.5.4 Report
Summary
Section Name:
Reinstatement request
Section Code:
1.5.4
Module Number:
1
Description:
Protocol amendment document in which an IND sponsor notifies FDA of their intent to resume clinical investigation after termination by the FDA
Submission Timing
Include in IND amendment (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources