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Objectives And Considerations In Developing An Integrated Summary Of Efficacy (ISE)

Source: Rho
rho

By Ben Vaughn

A new drug application (NDA) covers information about a product from inception through clinical trials. The integrated summary of efficacy (ISE) is a section of the NDA that provides a focused summary of efficacy data primarily from the pivotal phase 3 trials. This article discusses the primary goals and considerations for developing an ISE.