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CTD Section 1.17.1 Report

Summary
Section Name:
Correspondence regarding postmarketing commitments
Section Code:
1.17.1
Module Number:
1
Description:
This section contains information about postmarketing commitments that the sponsor has voluntarily agreed to undertake (such as gathering additional information about the approved drug's safety, effectiveness, or optimal use)
Submission Timing
Marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources