FDA Relaxes Clinical Trial Rules for Covid-19 Emergencies
March 23, 2020
(Bloomberg) – The coronvirus pandemic prompted the FDA to relax some clinical trial requirements, so last-minute decisions to safeguard research participants won’t trigger the agency’s enforcement arm. The Food and Drug Administration issued guidance Wednesday to help drug and device companies manage their clinical trials during the Covid-19 outbreak, the disease caused by the novel coronavirus SARS-CoV-2. Ongoing clinical trials face disruptions such as site closures, quarantines, travel limitations, and supply chain issues that could lead to shortages of the investigational drug or device, the agency noted.