AI, FDA

FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of new drugs and medical devices.
Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more
The FDA published its first draft guidance on the use of AI in the development of drugs and biological products
FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for artificial intelligence-enabled devices.
FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of their AI-enabled medical devices, said Troy Tazbaz, director of the FDA’s digital health center of excellence.
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.
FDA Issues Draft Guidance on AI-Enabled Medical Devices
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.
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FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
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A Win for AI in Cancer; 2025's Transformative Drugs; FDA Clarifies 'Underway' Trials
An AI system developed to predict a patient's response to immunotherapy could help "democratize" access to the pricey drugs ...
Demystifying AI
The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re ...
Health care AI, intended to save money, turns out to require a lot of expensive humans
This is a KFF Health News story. Preparing cancer patients for difficult decisions is an oncologist's job. At the University ...
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FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
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 ...
IBD 50's GeneDx Adds To Nearly 2,700% Sprint With FDA Guide On AI
Shares of the IBD 50's GeneDx surged Monday after the Food and Drug Administration issued guidance about using AI to develop ...