CTD Section 3.2.S.2.2 Report
Summary
Section Name:
Description of Manufacturing Process and Process Controls
Section Code:
3.2.S.2.2
Module Number:
3
Description:
Fully describe the manufacturing process and process controls, including how individual manufacturing runs are defined 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