The FDA’s Remote Regulatory Assessments: A Glimpse into the Future of Inspections
COVID-19 has fundamentally changed how clinical trials are conducted. In May 2021, FDA developed the ‘Resiliency Roadmap for FDA Inspectional Oversight’. In this document, FDA identified and embraced technological advancements by incorporating remote regulatory assessments (RRAs) into its inspection repertoire. During the pandemic, at a time where travel was restricted and personal contact heavily discouraged,...