European Medicines Agency Consultation: Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development

You are missing some Flash content that should appear here! Perhaps your browser cannot display it, or maybe it did not initialise correctly.

The European Medicines Agency has published a Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development.

The scope of this paper is the co-development of a new genomic biomarker and the relevant assay(s) in the context of either a drug development or for qualification purposes.

The document is available on the following webpage:

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin...

Comments should be provided using this template. The completed comments form should be sent to PGWPSecretariat@ema.europa.eu.

Please note that the deadline for comments is 30 November 2010.