NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission

A sponsor acquiring a therapeutic asset from an overseas company sought to include foreign clinical trial data, generated outside a U.S. IND, in a New Drug Application (NDA). The challenge lay in demonstrating the acceptability of efficacy and safety data from studies lacking ICH E3, formatted Clinical Study Reports (CSRs) and U.S.-specific regulatory elements.

Leveraging FDA’s 2012 guidance on foreign study acceptance, a regulatory gap analysis was conducted using the agency’s 11-point checklist. The Veristat team assessed Good Clinical Practice (GCP) compliance, documentation completeness, demographic comparability, and alignment with U.S. clinical norms. Veristat remediated gaps by creating cross-referenced ICH E3 maps, preparing supplemental documentation (including financial disclosures). Strategic recommendations addressed potential pre-approval inspection targets and supported FDA meeting readiness. This approach secured the inclusion of foreign trial data in the NDA, streamlined regulatory interactions, and positioned the sponsor to meet PDUFA timelines while maximizing the value of global clinical evidence.