European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation
Executive Summary
The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.
You may also be interested in...
Pharma Blames EU IVD Regulation For Clinical Trial Delays
The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many of such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.
EU IVD Regulation Delaying Clinical Trials Using Diagnostics
The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.
EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation
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.