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MedWatch 3500A template - Jan 2025 (Doc ID 3077649.1)

Last updated on MARCH 21, 2025

Applies to:

Oracle Life Sciences Argus Safety Cloud Service - Version 8.4.2 to 8.4.4 [Release 8.4]
Oracle Life Sciences Argus Safety - Version 8.4.2 to 8.4.4 [Release 8.4]
Information in this document applies to any platform.

Goal

FDA has released a new MedWatch Template for 2025 (01/25) for Manufacturers/User Facilities and Importers to submit adverse events reported for Drugs or Devices.

This document provides details on applying a workaround that upgrades the MedWatch drug report template from 2022 to 2025 version for Argus Safety versions 8.4.2.x, 8.4.3.x, and 8.4.4, and Safety One Argus 25.1.

 

Solution

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