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

Last updated on DECEMBER 01, 2021

Applies to:

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


What are the steps to configure a Biologic license?

Per the Oracle 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."



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