CTD Section 1.12.8 Report
Summary
Section Name:
Correspondence regarding exception from informed consent for research
Section Code:
1.12.8
Module Number:
1
Description:
Include any correspondance between the sponsor and FDA regarding exception from informed consent
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources