CTD Section 1.9.4 Report
Summary
Section Name:
Proposed pediatric study request and amendments
Section Code:
1.9.4
Module Number:
1
Description:
Document outlining the planned pediatric studies (or amendments) submitted for FDA approval
Submission Timing
Any submission prior to marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources