FDA Guidance - Search News

FDA, skin tone and Pulse oximetry

CNN on MSN · 14h

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased.

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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones. The long-awaited guidance released Monday comes in response to mounting evidence that the devices,

Minneapolis Star Tribune on MSN · 11h

FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone

The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients of color during the pandemic.

AI, FDA

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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug development.

Modern Healthcare · 19h

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The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of their AI-enabled medical devices, said Troy Tazbaz, director of the FDA’s digital health center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

Seeking Alpha on MSN · 18h

FDA issues first draft guidance on use of AI in drug, medical device development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increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of new drugs and medical devices.

lead, FDA and baby food

CNN on MSN · 14h

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.

The Associated Press - Busines… · 16h

FDA limits toxic lead in some baby foods

The U.S. Food and Drug Administration on Monday set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and dry cereal, part of an effort to cut young kids' exposure to the toxic metal that causes developmental and neurological problems.

FDA limits toxic lead in baby foods, aims to reduce exposure by up to 30%

The new guidance comes more than a year after lead-tainted pouches of apple cinnamon puree sickened more than 560 children in the US between October 2023 and April 2024, according to the CDC.

FiercePharma16h

FDA looks to clarify confirmatory trial mandate for accelerated approvals

In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...

16h

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 ...

Quality Assurance18h

FDA Releases Allergen, Food Safety and Plant-Based Alternative Labeling Guidance

The four new guidance documents are designed to help industry and other interest holders understand and comply with FDA ...

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