The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information ...
The FDA has responded to the increasing use of artificial intelligence (AI) in the discovery and development of drugs and ...
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) ...
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
The FDA has issued draft guidance to provides recommendations to sponsors and other interested parties on the use of artificial intelligence to ...
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.
Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...
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