FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
By Sneha S K and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's blockbuster cancer drug, Opdivo. Opdi
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FDA to update rules on what can be classified as ‘healthy’ coffee
One notable change to the guidelines allows coffee beverages- even those mixed with other ingredients- to be labeled as 'healthy' as long as they contain less than five calories per serving. The post FDA to update rules on what can be classified as ‘healthy’ coffee appeared first on The Manual.
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 1800s, when hucksters would sell elixirs claiming to be anti-inflammatory snake oil. Most of these products contained no snake oil and had no health benefits, sometimes even causing harm to consumers.
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for artificial intelligence-enabled devices.
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FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for

FDA, lead

FDA sets limits on lead in some baby foods
FDA limits toxic lead in some baby foods
 · 5hhealthday
Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food

FDA, skin and blood oxygen

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
FDA seeks to boost blood oxygen device accuracy across skin tones
The U.S. Food and Drug Administration on Monday proposed a new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones. The upda
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FDA Releases Draft Guidance for Labeling Plant-Based Animal-Derived Foods
Comment period is open for the public to review the new draft guidelines for labeling plant-based alternative foods.
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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 development.
FDA sets new limits for lead in baby food
The U.S. Food and Drug Administration announced new maximum allowable lead levels in baby foods for the first time to reduce potential health risks to infants
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MoCRA Guidance Update for Registration and Listing of Cosmetic Product Facilities and Products
What Happened: The Food and Drug Administration (FDA) released new guidance regarding the registration and listing of cosmetic product facilities and products. Who’s Impacted: Cosmetic product manufacturers. What Should You Do: Companies should consider submitting comments on this guidance by January 13, 2025.
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New Therapy Brings Hope for Dry AMD Vision Loss
The FDA has approved a first-of-its-kind treatment for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 55.