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Non-expedited Cases To US FDA Are Appearing In The 15 Day Alert Section In NDA Report (Doc ID 2869712.1)

Last updated on JULY 25, 2022

Applies to:

Oracle Argus Safety - Version 8.2.3 and later
Information in this document applies to any platform.

Goal

The following request was proposed as an enhancement to NDA Periodic reporting.

The NDA periodic (and other periodic reports as appropriate) should reflect the fact that non-expedited ICSRs submitted by companies on a rolling basis are
not 15 day alerts and are not classified as such.

The suggestion includes the ability to identify these as non-expedited reports and exclude them from the 15D alerts listing.
 

Solution

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In this Document
Goal
Solution
References


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