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Glossary

Integrated summary of Safety (ISS)

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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

R

Risk-benefit balance

An evaluation of the positive therapeutic effects of the medicinal product in relation to the…

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M

Medical Device Software

A “medical device software”, refers to a computer application that meets the legal definition of…

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