Update the EMDR E2B Profile to Meet FDA R2 Regulatory Requirements (Doc ID 2302788.1)

Last updated on AUGUST 30, 2017

Applies to:

Oracle Argus Safety - Version 8.1 and later
Information in this document applies to any platform.

Symptoms

The eMDR profile provided in 8.1.1 pre-release environment does not meet the R2 regulatory requirements provided by FDA.
The eMDR E2B profile needs to be update.
FDA provides ACK’s to all submissions done for the eMDR reports.


Cause

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