The unintentional theme of today’s issue is the struggle for control over how we implement AI in the U.S. On one side, where ...

The U.S. Digital Therapeutics Market encompasses software-driven solutions designed to prevent, manage, and treat medical conditions and diseases through evidence-based, clinically validated digital ...

Read about the move to scale use of AI across all FDA centers by the end of June and learn more about future plans to expand ...

There could be an upside to incorporating AI for the FDA. Using AI to assist in final drug reviews would "represent a chance ...

AI-powered tools are enhancing precision, efficiency, and decision-making in biopharmaceutical development. Recently, Jared ...

This article focuses on the common regulatory threads that connect different regions and the global standards and principles ...

The FDA  plans to launch generative AI across all of its centers by June 30. The agency has also appointed its first chief AI ...

The licensing rights include the U.S., where the FDA regulates drug and medical device development, so both companies expect that an acquisition will unlock growth opportunities and drive sustained ...

The Food and Drug Administration is rolling out an aggressive plan to make generative AI a linchpin in its decision-making, ...

In today’s digital transformation era, artificial intelligence (AI) is reshaping industries, and healthcare is no exception.

The FDA expects to fully integrate its AI approach by June 30, though its different centers have been instructed to start the ...

The US Food and Drug Administration (FDA) has set an "aggressive" timeline to implement generative artificial intelligence ...