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Why did FDA issue a recall over Cheese Puffs? Drama explained
Monosodium glutamate, or MSG, was one of the unreported flavor enhancers; according to the FDA, it is "generally recognized ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...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 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 ...
STAT5d
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 ...
FDA kicks off new year with draft guidance on skin biopsies in trials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 ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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.
STAT18h
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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
CORRECTION - OraQuick® HIV Self-Test Now Approved for Use in Adolescents
In a release issued under the same headline on Tuesday, January 7th by (NASDAQ: OSUR), please note that the first sentence of the release (read "OraQuick® HIV Self-Test that will increase access to ...