EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation
Executive Summary
A new Q&A document clarifies the interface between the EU regulations on clinical trials and in vitro diagnostics to support the coordinated assessment of studies involving the use of diagnostic assays.
You may also be interested in...
EU Explains Steps Sponsors Must Take When Using Companion Diagnostics In Drug Development
A new Q&A document from the European Medicines Agency outlines the key steps that pharma companies should take when using companion diagnostics in clinical trials, and the information it expects to see in marketing authorization applications.
EU Project To Evaluate Delays To Drug Trials Conducted Alongside Studies For IVDs/Devices
The European Commission is steering a new member state-driven project that aims to get to the bottom of factors causing delays to trials that simultaneously investigate a drug product with an IVD or a medical device, and propose some solutions.
EU Project To Evaluate Delays To Drug Trials Conducted In Combination With Studies For IVDs/Devices
The European Commission is steering a new member state driven project that aims to get to the bottom of factors causing delays to trials that simultaneously investigate a drug product with an IVD or a medical device, and propose some solutions.