Preparing an Integrated Summary of Safety: A Writer’s Perspective

The Integrated Summary of Safety (ISS) submitted with a New Drug Application is used by sponsors and regulators to evalutate a new drug’s safety profile. Preparing an ISS is a labor and intellectually intensive process requiring input from many areas of expertise within the pharmaceutical company including medical writing, regulatory affairs, clinical research, biometrics, data management, and programming. This article describes the approach to document production used at Parke-Davis Pharmaceutical Research Division of Warner Lambert Company and some guidelines for preparing an ISS from a writer’s perspective.