CTD Section 1.15.1.7 Report
Summary
Section Name:
Response to information request
Section Code:
1.15.1.7
Module Number:
1
Description:
If FDA issues an information request for additional information or clarification on an NDA or BLA, 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