CTD Section 3.2.S.4.3 Report
Summary
Section Name:
Validation of Analytical Procedures
Section Code:
3.2.S.4.3
Module Number:
3
Description:
Use this section to describe how the assays in 3.2.S.4.2 are validated, this is not typically required for original INDs for Phase 1 studies
Submission Timing
Include in initial IND if requested, update in annual reports
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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