CTD Section 3.2.P.3.4 Report
Summary
Section Name:
Controls of Critical Steps and Intermediates
Section Code:
3.2.P.3.4
Module Number:
3
Description:
Any critical steps and intermediates that were identified in section 3.2.P.3.3 should be discussed in further detail in this section. Describe the tests used to measure acceptance criteria that will be defined in 3.2.P.5.
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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