CTD Section 3.2.S.5 Report
Summary
Section Name:
Reference Standards or Materials
Section Code:
3.2.S.5
Module Number:
3
Description:
Provide details (e.g., source, lot, expiration date, COAs) on any well-characterized standards that are used to assess the characteristics of the 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