FDA’s COVID-19 Pandemic Plan Calls For Ongoing Clinical Trial Innovation
Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.
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Our infographic illustrates the recommendations in FDA’s COVID-19 pandemic recovery and preparedness plan, ranging from strengthening the EUA process to managing the backlog of pending inspections.
Shah, deputy commissioner for medical and scientific affairs, has been overseeing FDA’s COVID-19 Pandemic Recovery and Preparedness Plan. His departure the week of 20 January follows that of FDA Chief Counsel Amy Amin, whose resignation led to dueling appointments to temporarily fill her post.
Use of exploratory methods to understand as much as possible from the two Alzheimer’s disease drug trials that were terminated early for futility is the same type of ‘innovative thinking’ that will be needed to salvage information from neuroscience trials interrupted by the COVID-19, US FDA Office of Neuroscience director Billy Dunn says.