Via Faegre Drinker
“On March 18, the U.S. Food and Drug Administration (FDA) issued a final guidance titled FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic, providing important guidance for industry, investigators and institutional review boards on conducting clinical trials amidst the pandemic. The guidance, finalized without a public consultation period, describes FDA’s recognition of likely disruptions to clinical trials due to the pandemic and acknowledges that deviations from protocols will thus occur. It provides FDA’s current thinking on ways to mitigate the risks posed by these disruptions, focusing on patient safety, good clinical practice and trial integrity. “
“The guidance is applicable to all medical products (human drugs, biologics, and medical devices) undergoing clinical trials, including those being developed to prevent or treat COVID-19, and gives recommendations for both ongoing trials and trials for which procedures are not yet established. In recent days, other agencies have also released guidance on clinical studies impacted by COVID-19, including the National Institutes for Health (NIH) and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).”
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