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FDA, Skin Tones
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with diverse skin tones.
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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.
FDA seeks to boost blood oxygen device accuracy across skin tones
The U.S. Food and Drug Administration on Monday proposed a new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones. The upda
U.S. regulator aims to improve accuracy of blood oxygen devices for range of skin tones
The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones.
Lead, FDA and baby foods
FDA Sets New Levels for Toxic Lead in Baby Food
The FDA's new standards for toxic lead target processed baby foods such as jarred fruits, vegetables, yogurts and dry cereals.
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.
FDA Limits Toxic Lead in Some Baby Foods
The Food and Drug Administration has set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and dry cereal
14h
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
STAT
5d
Save the Food and Drug Administration by breaking it up
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...
9h
on MSN
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
19h
on MSN
Cheese Puffs Recall as FDA Issues Risk Warning
The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.
STAT
16h
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 ...
9h
on MSN
Ozempic 3.0? This drug causes the greatest weight loss — by far
Researchers from Canada reviewed the results of 26 trials to determine which of the weight loss jabs are the most effective ...
Pharmaceutical Technology
34m
FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
The FDA has accepted for filing and priority review Sentynl Therapeutics’ CUTX-101 NDA for the treatment of Menkes disease.
4d
on MSN
Pharma giant seeks to join lawsuit against FDA over weight loss drugs
Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by ...
3d
on MSN
FDA approves new drug for advanced Parkinson’s Disease
Thousands of Americans are diagnosed every year with Parkinson’s Disease. It’s a movement disorder that affects the central ...
Quality Assurance
18h
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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