EMA Explains Process For Assessing Suitability Of Biomarkers With Concerned Medicines
A new EU guideline outlines the steps that notified bodies can take to facilitate the European Medicines Agency’s assessment of the appropriateness of a companion diagnostic’s use with a drug.
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Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.
A compilation of the differences and similarities in regulatory requirements for decentralized trials across the EU member states could help sponsors better understand the nuances per country.
Drawing on lessons learnt from unprecedented interruptions to clinical trials over the past few years due to such things as the pandemic and the war in Ukraine, new advice has been issued on adjustments needed in clinical study reports to document these disruptions.