STAT April 19, 2024
Wendy Cheng

The Food and Drug Omnibus Reform Act of 2022 (FDORA), which was passed as part of the Consolidated Appropriations Act of 2023, will encourage greater diversity in clinical trials and help ensure new medications and treatments are developed with more representative populations in mind. But FDORA represents a paradigm shift for life sciences companies in the way individuals will be identified for clinical trials and enrolled in them, requiring companies to look closely at and rethink their current trial strategies.

FDORA will require trial sponsors to include diversity action plans for Phase 3 and other pivotal studies of new drugs and devices to contribute...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: AI (Artificial Intelligence), Biotechnology, FDA, Govt Agencies, Medical Devices, Pharma, Pharma / Biotech, Technology
Related Articles:
Chinese AI app DeepSeek was downloaded by millions. Deleting it might come next
Forget Billion-Dollar Companies—Will AI Create Billion-Dollar People?
Reid Hoffman enters 'wondrous and terrifying' world of health care with latest AI startup
The future of cardiac monitoring: AI-powered wearables in practice
Microsoft Unveils Surface Copilot+ PCs

Share This Article