CTD Section 1.5.1 Report
Summary
Section Name:
Withdrawal of an IND
Section Code:
1.5.1
Module Number:
1
Description:
Document in which sponsors notify the FDA of the decision to withdraw an IND (note: withdrawn or terminated INDs cannot be reactivated)
Submission Timing
Include in IND amendment (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources