CTD Section 3.2.S.2.4 Report
Summary
Section Name:
Controls of Critical Steps and Intermediates
Section Code:
3.2.S.2.4
Module Number:
3
Description:
Provide a description of the control of critical steps and intermediates in the manufacturing process, and include any in-process steps that are performed as critical control steps for each drug substance
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources