CTD Section 4.2.3.7.6 Report
Summary
Section Name:
Impurities
Section Code:
4.2.3.7.6
Module Number:
4
Description:
These studies assess the potential for impurities introduced by the manufacturing process to cause adverse effects
Submission Timing
As early as initial IND application, revise as necessary
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources