CTD Section 1.8.4 Report
Summary
Section Name:
Animal efficacy study for approval under the animal rule
Section Code:
1.8.4
Module Number:
1
Description:
Description of a proposed animal efficacy study that requires FDA feedback and guidance with accompanying questions
Submission Timing
Any submission prior to marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources