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AI, FDA

STAT · 3d

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The FDA published its first draft guidance on the use of AI in the development of drugs and biological products

Hosted on MSN · 1d

FDA releases guidance on artificial intelligence

The FDA is releasing the first-ever guidance on how the pharmaceutical industry can use AI. Nick Kostos and Femi Abebefe discuss the teams they believe can actually win the Super Bowl in February.

Modern Healthcare · 4d

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The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of their AI-enabled medical devices, said Troy Tazbaz, director of the FDA’s digital health center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.

aha.org · 3d

FDA issues draft guidance on marketing submissions for AI-enabled medical devices

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for artificial intelligence-enabled devices.

JD Supra · 2d

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.

STAT1d

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 ...

Hosted on MSN9h

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 ...

BioSpace3d

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 ...

14h

Demystifying AI

The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re ...

FDA aims to stem AI device bias, boost transparency in draft guidance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 ...

10h

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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