EMA Turns Down Ivermectin As COVID-19 Treatment
The EU medicines regulator found that results from clinical studies with ivermectin to treat COVID-19 were varied and inconclusive.
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US Needed Simple Pragmatic COVID-19 Trial For Repurposing Candidates, Woodcock Says
One such trial is being developed, but was needed early in the pandemic to answer many lingering questions about potential COVID-19 treatments.
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.
EU Guide Outlines Important Considerations For Submitting Complex Trials In CTIS
EU regulators have issued a new Q&A document on the key aspects that sponsors of complex trials should consider when making new submissions or moving ongoing studies to the Clinical Trials Information System.