CTD Section 5.3.3.1 Report
Summary
Section Name:
Healthy Subject PK and Initial Tolerability Study Reports
Section Code:
5.3.3.1
Module Number:
5
Description:
Many gene therapies do not have conventional PK properties, and are not typically tested in healthy subjects, so this section can remain empty
Submission Timing
Not applicable to gene therapies, not tested in healthy subjects
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources