Virginia Department of Education creates draft guidance on overdose response and notifications
The Virginia Department of Education is hosting a public comment meeting on Thursday, January 9, at 5:30 p.m. on its draft to ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
FDA Unveils Draft Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones
The FDA recommendations apply to only professional oximeters used in hospitals, doctor's offices, and other medical settings.
FDA issues draft guidance on developing weight loss drugs
New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments.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.
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
FDA issues first draft guidance on use of AI in drug, medical device development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 ...
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FDA draft guidance on labeling of plant-based foods ‘unfairly burdensome,’ says PBFA
The FDA does not favor commonly used descriptors such as ‘plant-based burger' on labels and suggests brands instead say ...
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FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
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FDA kicks off new year with draft guidance on skin biopsies in trials
The US Food and Drug Administration has issued guidance urging sponsors and trial sites to consider the necessity of the invasive procedure and gaining assent and consent from children ahead of trials ...
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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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA aims to stem AI device bias, boost transparency in draft guidance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 ...
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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.