Integrated Summary of Effectiveness and Integrated Summary of Safety

Integrated summaries of effectiveness (ISE) data and of safety (harms) data of more than one study, possibly including pooled/meta analyses, prepared for the FDA (required for New Drug Applications, and encouraged for Biologic License Applications). In the harmonized regulatory submission dossier, the Common Technical Document, the ISE and Integrated Summary of Safety (ISS) might be found in section “5.3.5.3 Reports of Analyses of Data from More than One Study (Including Any Formal Integrated Analyses, Meta-Analyses, and Bridging Analyses).”  The Summary of Clinical Efficacy (section 2.7.3 of the CTD) and Summary of Clinical Safety (section 2.7.4 of the CTD) were meant to replace the ISE and ISS.