New FDA proposal would put 'front-of-package' nutrition labels on food products
The U.S. Food and Drug Administration hopes "front-of-package" labeling will better improve the American population's health, ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...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FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
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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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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 sets new lead level guidelines for baby foods
FDA introduces guidelines for lead levels in processed baby foods, aiming to enhance infant safety and reduce exposure to ...
FDA issues first draft guidance on use of AI in drug, medical device development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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New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device ...
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FDA issues draft guidance on developing weight loss drugs
The U.S. FDA has released a new draft guidance for drugmakers to aid them in developing new treatments for obesity. The new document replaces an earlier draft guidance issued in February 2007.
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FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal ...
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When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for confirmatory trials for therapies seeking the shortened path to market.