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FDA New Element Transmit Mapping Removal - FDASAFETYREPORTTYPE [A.1.FDA.16] (Doc ID 2804984.1)

Last updated on JANUARY 18, 2022

Applies to:

Oracle Argus Safety
Oracle Argus Interchange
Information in this document applies to any platform.
.
1. Customers who have applied 8.9.9.87 patch on Oracle Argus Safety and are using standard FDA profiles for E2B R2 submissions

Or

2. Customers who are on version Oracle Argus Safety- 8.2.2.2/8.2.1.8 and are using standard FDA profiles for E2B R2 submissions




Purpose

The purpose of this document is to generate FDA E2B R2 report for DTD 2.1 and 2.2 profiles without the new data element FDASAFETYREPORTTYPE [A.1.FDA.16] introduced in patch 8.9.9.87 and versions 8.2.2.2, 8.2.1.8 so that there is no negative acknowledgement received from FDA.

Scope

FDA announced in April 2021 that the new element FDASAFETYREPORTTYPE [A.1.FDA.16] is mandatory to be sent from June 28 2021 to avoid negative acknowledgements from FDA.

Based on this announcement, the new element was introduced in 8.2.1.8 and 8.2.2.2 releases and subsequently as version independent patch 8.9.9.87 for other Argus versions for the below FDA profiles:

 

 

However, FDA revised the guidelines in June 2021 stating that the new element FDASAFETYREPORTTYPE [A.1.FDA.16] implementation date is postponed and the companies need to continue to submit post marketing safety reports using the current DTD 2.1 or DTD 2.2 without the new regional element.

 

FDA sends negative ACK if the new element is included in the E2B R2 report

 

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions

Details

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In this Document
Purpose
Scope
Details

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