Will FDORA Impact My Clinical Research Practice?

In December 2022, President Biden approved the Consolidated Appropriations Act, a comprehensive piece of legislation earmarking funds for the U.S. government throughout 2023. Embedded within this significant bill is the FDA Omnibus Reform Act of 2022 (FDORA), a legislative measure addressing a broad spectrum of issues and topics of clinical research. This makes FDORA crucial information for research sites navigating the landscape of evolving regulations.

While the complete ramifications of FDORA on day-to-day trial operations are still unfolding, it is evident that the act will influence research practices in four key areas: Diversity Action plans, decentralized trial guidance, digital health technology guidance, and BIMO inspection updates. Each of these components carries substantial weight in shaping the future of clinical research.

This article explores the details of each provision, shedding light on their importance and offering guidance on how to proactively respond to the changes ushered in by FDORA. By delving into these critical aspects, research sites can better understand and navigate the evolving regulatory framework, ensuring compliance and optimal functioning in the realm of clinical trials.