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Enabling Clinical Trial Innovation Through AI Regulation at FDA
MedCity News July 29, 2024
As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility.
Innovation is not just a luxury but a necessity in the realm of clinical trials, particularly as we strive to accelerate drug development. Yet, the slow pace of innovation within the U.S. clinical trials system has impeded progress, leaving many stakeholders frustrated. U.S. Food and Drug Administration (FDA) resource limitations cause the inadvertent prioritization of programs sponsored by pharmaceutical companies, resulting in a bottleneck that stifles the adoption of more efficient and patient-friendly methods. Thus, expected breakthroughs from pharma have not materialized, leaving patients and researchers at a standstill.
Pharmaceutical companies...
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