CTD Section 3.2.P.4.6 Report
Summary
Section Name:
Novel Excipients
Section Code:
3.2.P.4.6
Module Number:
3
Description:
For excipients used for the first time in a drug product (or route of administration), provide the full details of manufacture, characterization, and controls. If possible, cross-reference to supporting safety data in a regulatory filing.
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources