CTD Section 3.2.P.4.5 Report
Summary
Section Name:
Excipients of Human or Animal Origin
Section Code:
3.2.P.4.5
Module Number:
3
Description:
In this section, provide information regarding the source, specification, description of testing, and viral safety data for any excipients of human or animal origin. If human serum is used, submit information on infectious disease testing and donor suitability.
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources