CTD Section 1.6.1 Report
Summary
Section Name:
Meeting request
Section Code:
1.6.1
Module Number:
1
Description:
Letter to FDA formally requesting a meeting (typically the pre-IND meeting for initial INDs)
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources