DEVICE MANUFACTURING SITE ON DRUG MEDWATCH
(Doc ID 1503715.1)
Last updated on FEBRUARY 01, 2021
Applies to:Oracle Argus Safety - Version 7.0.1 and later
Information in this document applies to any platform.
***Checked for relevance on 30-Jul-2014***
Oracle Argus Safety Version 7.0.1
When a MedWatch 3500 A Drug is generated for a drug product, the Manufacturing Site for Devices is included in section G.1: ALL MANUFACTURERS.
The Manufacturing site should not be included in the MedWatch form for Drugs.
It should be included for devices only.
How can we suppress the Manufacturing Site in MedWatch forms for Drugs?
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