8 Key Takeaways For FDA Inspections In The FDORA

By Donald Ashley and Kalah Auchincloss

With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools for inspection, mutual recognition agreements, bioresearch monitoring, and unannounced foreign inspections.