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

Last updated on DECEMBER 04, 2023

Applies to:

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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