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Glossary

Integrated summary of efficacy (or effectiveness) (ISE)

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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

S

Serious Adverse Event (SAE)

Adverse event (AE) means any untoward medical occurrence associated with the use of a drug…

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D

Disease Risk-factor Reduction Claims (RDRC)

Possibly the highest level of medicine-like health claim that can be made on a non-drug…

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