My Oracle Support Banner

Argus Safety - CBER Revised Guidance in June 2020 for eVAERS Submissions (Doc ID 2707701.1)

Last updated on JANUARY 25, 2022

Applies to:

Oracle Argus Safety - Version 8.2.2 to 8.2.2 [Release 8.2]
Information in this document applies to any platform.

Goal

The purpose of this document is to provide a workaround for the latest regulation updates published in June 2020 by the Center for Biologics Evaluation and Research (CBER).

The compliance date for Combination Product Applicants to report ICSRs using the latest guidance is January 31, 2021.

These requirements are implemented in Argus 8.2.3 as enhancement request 31557002 - eVAERS Regulatory Updates Jun 2020.

Solution

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!


In this Document
Goal
Solution
References

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.