Voisin Consulting Life Sciences glossary icon
Glossary

Integrated summary of Safety (ISS)

Click a letter to view all its definitions

Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an NDA or BLA in the US.

Other glossary definitions

I

Incident for IVDMD (IVDR definition)

Any malfunction or deterioration in the characteristics or performance of a device made available on…

View definition
D

Development international birth date (DIBD)

Date of first approval (or authorization) for conducting an interventional clinical trial in any country…

View definition

Voisin Consulting Life Sciences widget icon about us

Voisin Consulting Life Sciences widget icon our expertise

Voisin Consulting Life Sciences
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.