CTD Section 1.4.1 Report
Summary
Section Name:
Letter of authorization
Section Code:
1.4.1
Module Number:
1
Description:
Document provided by the Sponsor of another IND, allowing FDA to review potentially proprietary information without having to disclose that information to the Sponsor of the new IND
Submission Timing
Include in initial IND or amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources