Is Argus Compliant With September 1, 2016, the ESG CDER (Center for Drug Evaluation and Research) Acknowledgement often referred to as the “second acknowledgement” Revision. (Doc ID 2170836.1)

Last updated on AUGUST 18, 2016

Applies to:

Oracle Argus Interchange - Version 7.0.1 and later
Information in this document applies to any platform.

Goal

Change requirement for ESG CDER (Center for Drug Evaluation and Research)

Beginning September 1, 2016, the ESG CDER (Center for Drug Evaluation and Research) Acknowledgement often referred to as the “second acknowledgement”, will be revised.
The revised acknowledgement message contains additional information about your submission and is easier to read.
The revised acknowledgement pertains to CDER only; the other FDA Centers are not affected.

If you are an AS2 (system-to-system) user, you will have to make sure your system is able to receive and process updated acknowledgement for CDER submissions; while all other Center acknowledgements remain the same.

Is Argus compliant with these new requirements?
 

Solution

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