FDA, AI

FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug development.
FDA issues first draft guidance on use of AI in drug, medical device development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increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of new drugs and medical devices.
FDA issues first guidance on AI in medicine development
The FDA has responded to the increasing use of artificial intelligence (AI) in the discovery and development of drugs and biologics by publishing its first provisional guidance on the technology's use in regulatory filings.
FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for artificial intelligence-enabled devices.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The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of their AI-enabled medical devices, said Troy Tazbaz, director of the FDA’s digital health center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FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device's Total Product Life Cycle.
Tempus AI up after FDA issues draft guidance on AI use in drug decision making
The FDA has issued draft guidance to provides recommendations to sponsors and other interested parties on the use of artificial intelligence to
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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 ...
FDA weighs novel pain drug amid opioid crisis
The FDA will decide later this month whether to approve a novel drug for acute pain that could offer a nonaddictive ...
FDA aims to stem AI device bias, boost transparency in draft guidance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 ...
The Pharma Letter2d
FDA framework to advance AI models used for drug and biological filings
The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial ...
JD Supra1d
JPM2025: Regulation of artificial intelligence: Navigating a new frontier in health care
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...