CTD Section 2.7.5 Report
Summary
Section Name:
References - List of References
Section Code:
2.7.5
Module Number:
2
Description:
All references cited in the clinical summary should be provided. Include copies of especially important references in Module 5.4, and indicate on the references list which are available in that section. Have backup copies of all references available if FDA requests them
Submission Timing
As early as initial IND application (see note), completed by marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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