A.1.FDA.15 Combination Product Report Flag Shows as No in FDA E2B(R2) 2.2 report (Doc ID 2709785.1)

Last updated on JANUARY 03, 2025

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.1 and later
Information in this document applies to any platform.

Issue:

A.1.FDA.15 combination product flag shows as 2 which is No in FDA E2B(R2) 2.2 report.

Steps:

1. Open the case

2. Configure the combination product in the product tab

3. Schedule FDA E2B(R2) 2.2 report in the regulatory report tab

4. Click the draft link to view the report

5. Review the output value in A.1.FDA.15 <combinationproductreport>

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In this Document

Symptoms

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