MedWatch 3500A January 2025 updates

Summary

MedWatch 3500A template enhanced for January 2025 version (Bug 37562381)

Description

The MedWatch drug report generated in Argus is updated based on the January 2025 version of the MedWatch 3500A template published by the FDA. The changes are as follows:

• Box 3a Sex is renamed to 3 Sex and the Undifferentiated and Decline to answer options are removed.
• The contents of Box 3b are removed and the Section removed text is displayed in the box that before was used for printing box 3b Gender information.
• The Footer of the report is changed from Form FDA-3500A MedWatch(11/22) to Form FDA-3500A MedWatch(01/25).
• Content related to Privacy Act Statement / PRA information has been revised as per the latest template.