5 Ways FDORA Will Impact Clinical Research Sponsors: And What You Need To Do About It

At the end of December 2022, President Joe Biden signed the Consolidated Appropriations Act to fund the U.S. government for the 2023 fiscal year.1 The bill contains the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act), legislation focused on strengthening the nation’s public health, medical preparedness, and response systems in the wake of the COVID-19 pandemic. The bill also contains the FDA Omnibus Reform Act of 2022 (FDORA), a law that addresses clinical trial diversity, the FDA’s accelerated approval process, decentralized trials, Bioresearch Monitoring (BIMO) inspections, and other areas of research.

Though PREVENT has important provisions that will help protect the country and the globe from future pandemics, FDORA’s impacts on daily trial operations are still unfolding, and nothing is moving fast. While the act will change aspects of clinical research across the board, explore five main ways studies are already being impacted and what trial teams can do about it.