New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
JD Supra6d
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management ...
New FDA proposal would put 'front-of-package' nutrition labels on food products
The U.S. Food and Drug Administration hopes "front-of-package" labeling will better improve the American population's health, ...
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AI Drug Development: FDA Releases Draft Guidance
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial ...
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FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
FDA issues draft guidance on developing weight loss drugs
New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments. Read more here.
FDA disappoints child advocates with its new limit on lead in baby food
For the first time, the US Food and Drug Administration has set a limit on the amount of lead that can be in baby foods, but critics say it’s too little, too late.