My Oracle Support Banner

MedWatch Not Showing Biologic License as BLA (Doc ID 2803347.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.2 and later
Information in this document applies to any platform.

Goal

What are the steps to configure a Biologic license?

Per the Oracle Life Sciences Argus Safety Administrator’s Guide, the 'Biologic / Vaccine' checkbox determines:

"Whether the license is for a Biologic/Vaccine (this can impact reporting rule). If this is option is checked MedWatch will print PLA# not NDA# in section G5. It is included to support the Biologic License Application (BLA) and the Product License Application (PLA) requirements."


 

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


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