A Visual Guide To How FDA Can Manage The Pandemic
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.
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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.
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.
If agency has concerns about facilities it cannot inspect, it will generally issue complete responses, Q&A guidance says.