3 Key Questions When Developing The Integrated Summary Of Safety (ISS)

By Rob Woolson

A New Drug Application (NDA) covers information about a product from inception through clinical trials. The integrated summary of safety (ISS) is a section of the NDA that provides comprehensive safety information collected throughout the development program. The goal of the ISS is to characterize the overall safety profile of the drug and to identify risks that should be included on the product label. This article discusses three key questions to address as a part of your ISS analysis plan.