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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

P

Post-market surveillance

All activities carried out by manufacturers in cooperation with other economic operators to institute and…

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A

Anonymization Report (AR)

Part of the Policy 70 submission package. It should describe the methodology of the anonymisation…

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