Commission asked to involve EMA in regulating companion diagnostics
This article was originally published in Clinica
Executive Summary
The European Commission's consultation on revising the In Vitro Diagnostics Directive (98/79/EC) has revealed that some stakeholders want the European Medicines Agency to become involved in regulating companion diagnostics, ie IVDs that are developed and used in direct combination with a specific medicinal product (www.clinica.co.uk, 24 February 2011).