CTD Section 3.2.P.5.1 Report
Summary
Section Name:
Specification(s)
Section Code:
3.2.P.5.1
Module Number:
3
Description:
Provide specifications to adequately describe physical, chemical or biological characteristics of the drug product
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources