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CTD Section 1.17.2 Report

Summary
Section Name:
Correspondence regarding postmarketing requirements
Section Code:
1.17.2
Module Number:
1
Description:
This section contains information about FDA required studies that the sponsor must perform after the drug has been approved
Submission Timing
Marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources