CTD Section 1.15.1.6 Report
Summary
Section Name:
Response to untitled letter or warning letter
Section Code:
1.15.1.6
Module Number:
1
Description:
If FDA issues an untitled letter or warning letter for promotional materials that do not comply with regulations, the Sponsor should place their response in this section
Submission Timing
Include in marketing application (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources