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.
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.
All activities carried out by manufacturers in cooperation with other economic operators to institute and…
View definitionPart of the Policy 70 submission package. It should describe the methodology of the anonymisation…
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