What Does ISS Stand For?

ISS stands for Integrated Summary Of Safety

The Integrated Summary of Safety (ISS) is a comprehensive document that consolidates safety data related to a pharmaceutical product. It provides an organized synthesis of available safety information from clinical trials, post-marketing surveillance, and other relevant sources. The ISS is designed to facilitate regulatory submissions and safety assessments by presenting a clear overview of the product's risk profile, highlighting significant safety issues, and summarizing findings that inform healthcare professionals and regulatory bodies about the product's safety and efficacy.