CTD Section 1.4.2 Report
Summary
Section Name:
Statement of right of reference
Section Code:
1.4.2
Module Number:
1
Description:
Document is similar to the letter of authorization, but is provided by the holder of a Drug Master File rather than an 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