Eli Lilly shares drop as drugmaker cuts revenue guidance on weight loss drug demand
Eli Lilly shares dropped after the drugmaker cut its 2024 revenue guidance, citing lower-than-expected demand for its obesity ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...
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FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations
The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization ...
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FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
The FDA Set Guidelines for 'Acceptable' Levels of Lead in Baby Food for the First Time — but Some Experts Say It's Not Enough
On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an ...
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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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA issues draft guidance on developing weight loss drugs
New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments.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.
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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
In 2013, the FDA issued premarket guidance for developers of pulse oximeters in which it recommended that they have “a range of skin pigmentation” represented in their clinical testing of the ...
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Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food
TUESDAY, Jan. 7, 2025 (HealthDay News) -- The U.S. Food and Drug Association (FDA) released the first-ever guidelines for ...
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Advocates Say FDA Guidance on Lead Levels in Baby Food Is Insufficient
The first-ever US FDA guidelines on lead in baby food are under fire from health experts who argue the limits are too lenient.