Why the Case is Displayed Twice in the NDA Periodic Report Once in the S/L Section and Again in the S/UL Section?
Last updated on JANUARY 17, 2012
Applies to:Oracle Argus Safety - Version: 220.127.116.11
Information in this document applies to any platform.
Scenario: The case was initially reported to the FDA as a Serious Unlisted case within the Periodic report time frame. Follow-up information was received and the case was downgraded to a Serious Listed case. The downgrade occurred outside of the reporting time frame. The NDA report now list the case twice. Once in the S/L section and again in the S/UL section.
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