Locked Literature Cases are Pulled in Under Cases not Included In Report Section (PADER) (Doc ID 2878153.1)

Last updated on JULY 13, 2023

Applies to:

Goal

Literature cases are incorrectly appearing in the "Cases not included in the report" section of the NDA report when 'Exclude Literature Cases' is unchecked in the inclusion Criteria.

This issue is observed in the following scenarios:

a) A 15-day literature case that is locked is either listed in the '15 day Submission Cases' section or 'Cases Sent As FDA 3500As Under Another NDA' due to the presence of a submitted report for another license.

b) A Non 15-day literature case (Serious/Listed, Non-Serious/Listed, Non-Serious/Unlisted) that is locked.

Solution

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