CTD Section 1.9.3 Report
Summary
Section Name:
Request for pediatric exclusivity determination
Section Code:
1.9.3
Module Number:
1
Description:
Request by Sponsor for FDA to grant pediatric exclusivity for additional marketing exclusivity for pediatric designation
Submission Timing
Any submission prior to marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources