Why the Case is Displayed Twice in the NDA Periodic Report Once in the S/L Section and Again in the S/UL Section? (Doc ID 1159472.1)

Last updated on JULY 13, 2023

Applies to:

Goal

Why is the case displayed twice in the NDA periodic report--once in the S/L section and again in the S/UL section in the following scenario?

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.

Solution

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