The FDA's Remote Regulatory Assessments: A Glimpse Into The Future Of Inspections

By Marc Wartenberger, Director, CRIO

The COVID-19 pandemic necessitated a shift in the FDA's inspection strategy, leading to the adoption of Remote Regulatory Assessments (RRAs). These assessments, leveraging video conferencing, file sharing, and remote access, became crucial when traditional in-person inspections were hindered. By late 2021, the FDA had conducted over 800 RRAs globally, with a mix of voluntary and mandatory participation.

RRAs provide distinct advantages over traditional inspections, such as increased efficiency, reduced travel costs, and enhanced global oversight capabilities. They require thorough preparation, including understanding FDA guidance, ensuring robust technological infrastructure, and organizing pertinent records. CRIO facilitates this process by streamlining document management and data access, thereby easing preparation burdens and enhancing compliance and data integrity. RRAs have emerged as an essential mechanism for maintaining regulatory oversight in the clinical trials sector during the pandemic. By adopting digital platforms sponsors can optimize their readiness for RRAs, fostering more efficient and successful engagements with the FDA.