CTD Section 1.13.14 Report
Summary
Section Name:
Log of outstanding regulatory business
Section Code:
1.13.14
Module Number:
1
Description:
If there is any outstanding business with FDA with respect to the IND application for which the sponsor requests or expects a reply, comment or meeting, include that information in the annual report
Submission Timing
IND amendments (annual reports only and if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources