Biden FDA moves forward with rule to lower nicotine in cigarettes, a ‘gift’ to cartels, critic says
Opponents argue that the change could cause current smokers to use more cigarettes to compensate for the lower nicotine ...
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Leaving FDA, Califf is unapologetic — and warns of staff departures
In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 sets limits for lead in many baby foods as California disclosure law takes effect
The FDA has set maximum levels for lead in baby food. A new California law requires baby food makers selling products in the ...
STAT1d
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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
FDA limits toxic lead in some baby foods – here's what to know
The FDA has set maximum levels for lead in packaged processed foods sold in jars, pouches, tubs or boxes. Here's what to know ...
FDA issues draft guidance on developing weight loss drugs
The U.S. FDA has released a new draft guidance for drugmakers to aid them in developing new treatments for obesity. The new ...
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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 ...
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FDA draft guidance on labeling of plant-based foods ‘unfairly burdensome,’ says PBFA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 ...
FDA Limits Toxic Lead in Some Baby Foods
The agency issued final guidance that it estimated could reduce lead exposure from processed baby foods by about 20% to 30%.