Default MedWatch profile used for NDA reporting

Summary

Default MedWatch profile used for NDA report (38240551, 38330511)

Description

A new common profile switch is provided for accurate case categorization in NDA/PADER periodic safety reports, when the Primary Agency is not linked to a MedWatch profile. This enhancement resolves prior misclassification of cases as initial submissions instead of follow-ups in Tab1 line listing of NDA report and incorrect report sequence number in MedWatch reports generated as part of NDA report.

The common profile switch, Default MedWatch Profile used for NDA report if Primary Agency is not configured with MedWatch Profile, is added under System Configuration > Common Profile Switches > Reporting > Periodic and it is set to FDA MEDWATCH 3500A DRUG TEMPLATE by default. This switch displays a list of factory-defined and custom-created MedWatch profiles.

If the Primary Agency set in NDA/PADER does not have an associated MedWatch profile, the system uses the profile specified in a common profile switch to generate a MedWatch report when Line listing- Tab 1: FDA-3500A / VAERS Forms is selected in the NDA/PADER periodic report.