Commission asked to involve EMA in regulating companion diagnostics
This article was originally published in Clinica
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).
You may also be interested in...
Drug companies in the EU explain how a new pilot scheme on national-level scientific advice service can benefit drug developers.
While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.