CTD Section 5.3.6 Report
Summary
Section Name:
Reports of Postmarketing Experience
Section Code:
5.3.6
Module Number:
5
Description:
This section should include reports that summarize marketing experience for products that are currently marketed
Submission Timing
As early as initial IND application, revise as necessary
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources