CTD Section 1.12.6 Report
Summary
Section Name:
Exception from informed consent for emergency research
Section Code:
1.12.6
Module Number:
1
Description:
Request by the sponsor for FDA to grant exception for informed consent in emergency cases
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources