[FDA] The ISE is a comprehensive integrated analysis of the effectiveness of a study drug. The purpose of the ISE is to describe the available information regarding effectiveness, delineate strengths and weaknesses, and highlight important missing information. Generally, analyses in the ISE are based primarily on the clinical effectiveness data included in the application, but they may also include other sources of information relevant to efficacy.
Since 1985, the regulation under 21 CFR 314.50(d)(5)(v) has required that the ISE be part of an NDA submission.
Source: Integrated Summary of Effectiveness Guidance for Industry
