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FDA E2B(2) 2.2 DTD Combination Product Best Practices Document Release 8.9.9.89 (Doc ID 2537782.1)

Last updated on DECEMBER 19, 2019

Applies to:

Oracle Argus Safety
Oracle Argus Interchange
Generic (Platform Independent)

Purpose

 

Oracle Argus Safety

FDA E2B(2) 2.2 DTD Best Practices Document

Release 8.9.9.89

 

Oracle Argus Safety 8.9.9.89 provides solution for the Post Marketing Safety Reporting (PMSR) of combination products that have received FDA marketing authorization.

While the FDA’s Combination Product reporting guidelines is in draft, Oracle plans to release the solution for Combination Product Reporting in phases.

Oracle Argus Safety 8.9.9.89 patch is the first phase of the solution that comprises of FDA E2B DTD 2.2 profile and the corresponding back-end table to store the PMOA and Constituent Product relation at Case level. 

After the final guidelines are published by FDA, Oracle plans to release complete solution for Combination Product Reporting that comprises of UI changes to Console and Case Form along with FDA E2B DTD 2.2 profile and the back-end table.

When the complete solution is available, all the customers using 8.9.9.89 patch need to uptake the this release for Combination Product reporting and Argus Safety 8.9.9.89 patch would be made obsolete.

Scope

This document provides information on how to perform ICSR reporting to the FDA using the FDA E2B(R2) 2.2 DTD profile instead of the E2B(R2) 2.1 DTD profile, as well as special considerations about FDA E2B(R2) 2.2 report that is provided in this release.

The document contains the following sections:

 

 

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