CTD Section 3.2.S.4.4 Report
Summary
Section Name:
Batch Analyses
Section Code:
3.2.S.4.4
Module Number:
3
Description:
Include a table in this section with the test results of each batch, indicating whether batches were manufactured in different ways or if any fail to met release specifications
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources