FDA's 3rd Acknowledgment - Is Argus able to handle this ?

(Doc ID 2168390.1)

Last updated on AUGUST 04, 2016

Applies to:

Oracle Argus Safety - Version 7.0.3 and later
Information in this document applies to any platform.


Oracle Argus Safety Version 7.0.3

Customer has received today (2016-08-02), a message from FDA about a 3rd acknowledgment.

Particular reference to the note below in the above e-mail:

4. -> b. b. 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.


1. Has Oracle been notified about this 3rd acknowledgment ?
2. Is there an example of what the 3rd Ack will look like ?
3. Will ESM will be able to handle this 3rd acknowledgment ? (If no, how to fix ?)


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