Concept paper on good genomics biomarker practices

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Download document Concept paper on good genomics biomarker practices
Reference number EMA/CHMP/PGWP/415990/2014
Status draft: consultation closed
First published 04/08/2014
Last updated 04/08/2014

Summary

Genomic data have become important to evaluate efficacy and safety of a drug for regulatory approval. As a result, genomic information has been increasingly included in drug labels relevant for the benefit/risk evaluation of a drug and consequently as guidance for patient treatment.