BioPharma Dive May 6, 2024
The FDA Omnibus Reform Act (FDORA) impacts clinical research in many ways — from decentralized trial guidance and digital health technologies guidance to BIMO inspection updates and changes to the accelerated approval process. One of the most significant impacts, however, is the new FDORA diversity action plan requirement.
Diversity action plans are now a requirement for clinical trial sponsors, including Phase III, pivotal, and some device studies. FDORA also expands the FDA’s diversity focus beyond race and ethnicity to include other demographics such as sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity. With these factors now codified into law, optimized hybrid and site-less clinical trials are the most straightforward path for sponsors to align with...
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