This guidance describes the recommended content of the integrated summary of effectiveness (ISE) for inclusion in a new drug application (NDA) or biologics license application (BLA). Although there are no regulations requiring an ISE for BLA submissions, applicants are encouraged to provide an ISE because it represents an opportunity to present a coherent analysis and presentation of the drug’s benefits.
The recommendations in this guidance reflect the FDA’s current thinking regarding information that industry should include in an ISE to provide an integrated analysis that offers insights beyond those observable in individual clinical trials. This guidance does not apply to medical devices regulated as biologics under the Public Health Service Act.
This guidance supersedes section II.G., Integrated Summary of Effectiveness Data, of the guidance for industry Guideline for the Format and Content of the Clinical and Statistical Sections of an Application (Clin-Stat guidance). It also incorporates the conceptual framework of section 2.7.3, Summary of Clinical Efficacy (SCE), from the ICH guidance for industry M4E The CTD — Efficacy.