FAERS E2B(R3) updates for IND report

Summary

FAERS profile support for use cases with pre-ANDA and spontaneous IND causality validation (Enhancement 38191786)

Description

While generating an IND report from a spontaneous case, the system currently enforces a validation requiring at least one causality assessment source to be Sponsor. However, in the IND reports generated from spontaneous cases, the source may not always be a sponsor—it could be the Marketing Authorization Holder (MAH) or the pharmaceutical company itself.

In FAERS, the existing validation that enforces source to be a sponsor (Source = Sponsor) is removed for the IND report generated from spontaneous cases.

For spontaneous IND reports, the system now allows any value for the causality assessment source (like MAH or pharma company). The causality assessment is directly mapped to the following elements:

• DRUGASSESSMENTSOURCE [G.k.9.i.2.r.1]
• DRUGASSESSMENTMETHOD [G.k.9.i.2.r.2]
• DRUGRESULT [G.k.9.i.2.r.3]