European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation
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.
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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 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.
Global Medtech Guidance Tracker: May 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.