Would An Independent Analysis Of US FDA's Pandemic Response Find Transformative Effect?
Group of outside experts could help the agency determine the pandemic-inspired practices and regulatory changes to keep, former commissioner von Eschenbach says.
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PDUFA VII Could Expand US Real-Time Review Beyond Oncology
A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.
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.
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.