ISS (Integrated summary of safety):Integrates safety information from all sources (animal, clinical pharmacology, controlled and uncontrolled studies, epidemiologic data). “ISS is, in part, simply a summation of data from individual studies and, in part, a new analysis that goes BEYOND what can be DONE with individual studies.”ISE (Integrated Summary of efficacy)ISS & ISE are CRITICAL COMPONENTS of the safety and effectiveness submission and expected to be submitted in the application in accordance with regulation. FDA’s guidance FORMAT and Content of Clinical and Statistical Sections of Application gives advice on how to construct these summaries. Note that, despite the name, these are integrated analyses of all relevant data, not summaries.

ISS (Integrated summary of safety):Integrates safety information from all sources (animal, clinical pharmacology, controlled and uncontrolled studies, epidemiologic data). “ISS is, in part, simply a summation of data from individual studies and, in part, a new analysis that goes beyond what can be done with individual studies.”ISE (Integrated Summary of efficacy)ISS & ISE are critical components of the safety and effectiveness submission and expected to be submitted in the application in accordance with regulation. FDA’s guidance Format and Content of Clinical and Statistical Sections of Application gives advice on how to construct these summaries. Note that, despite the name, these are integrated analyses of all relevant data, not summaries.