CTD Section 1.13.6 Report
Summary
Section Name:
Summary of microbiological changes
Section Code:
1.13.6
Module Number:
1
Description:
In the Sponsor's annual report, if there are updates to microbiological parameters, those changes should be reported in this section
Submission Timing
IND amendments (annual reports only and if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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