Glossary Terms

Integrated Summary of Effectiveness

A document, prepared for inclusion in a new drug application (NDA) or biologics license application (BLA) in the United States, which includes a detailed set of integrated analyses of all relevant data from the clinical study reports. The ISE is required in applications submitted to the FDA, in accordance with the regulations for NDA submissions (21 CFR 314.50(d)(5)(v) and 21 CFR 314.50(d)(5)(vi)(a), respectively).

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