CTD Section 1.12.13 Report
Summary
Section Name:
Request for waiver for in vivo studies
Section Code:
1.12.13
Module Number:
1
Description:
This section is to request a waiver of any in vivo studies outside of those in-vivo bioavailability studies that are required for generic drug development
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources