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BioWorld - Sunday, September 24, 2023
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Home » White paper delves into US regulatory aspects of AI in drug, device development
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White paper delves into US regulatory aspects of AI in drug, device development

Sep. 7, 2023
By Mari Serebrov
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While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee.
BioWorld BioWorld MedTech Medical devices and technologies Regulatory U.S. FDA

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