CTD Section 3.2.A.2 Report
Summary
Section Name:
Adventitious Agents Safety Evaluation [name, dosage form, manufacturer]
Section Code:
3.2.A.2
Module Number:
3
Description:
In this appendix, provide information assessing the risk of potential adventitious agent contamination, COAs for raw materials and reagents, study reports and data collected for adventitious agent testing
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources