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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 Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…

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I

Important Missing Information

Critical gaps in knowledge for specific safety issues or populations that use the marketed product.

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