CTD Section 1.8.2 Report
Summary
Section Name:
Carcinogenicity study
Section Code:
1.8.2
Module Number:
1
Description:
Description of a proposed carcinogenicity 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