One of Janet Woodcock’s lessons learned from the coronavirus pandemic was that a simple clinical trial to test repurposed medications was necessary earlier to answer questions that are still lingering one year later.
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.
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
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Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
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As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.