CTD Section 1.16.2.5 Report
Summary
Section Name:
REMS Correspondence
Section Code:
1.16.2.5
Module Number:
1
Description:
Include any correspondance between the sponsor and FDA asking for additional guidance on the REMS plan
Submission Timing
Include in marketing application, postmarketing amendment
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources