Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle

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Download document Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle
Reference number EMA/CHMP/800914/2016
Status draft: consultation open
First published 2017-07-28
Last updated 2017-07-28
Consultation start date 2017-07-28
Consultation end date 2017-11-15
Email address for submissions pgwpsecretariat@ema.europa.eu

Summary

The proposed concept paper is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. The guideline will provide recommendations on the interface between predictive biomarker-based assays including companion diagnostic and the development and lifecycle of a medicine.