CTD Section 1.12.16 Report
Summary
Section Name:
Field alert reports
Section Code:
1.12.16
Module Number:
1
Description:
A report submitted by the sponsor if they learn of certain issues in already distributed products that cause product to fail to meet established specifications, including mislabelling on packaging, contamination, significant chemical or physical changes, or deterioration
Submission Timing
IND amendment only (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources