CTD Section 1.9.6 Report
Summary
Section Name:
Other correspondence regarding pediatric exclusivity or study plans
Section Code:
1.9.6
Module Number:
1
Description:
Summary document that contains any correspondance between the sponsor and the FDA regarding pediatric studies or PREA requirements
Submission Timing
Any submission prior to marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources