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278 articles found
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FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical TrialsToday, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as... -
FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product SubmissionsToday, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biolo...
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FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical DevicesToday, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s T...
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FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin TonesToday, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care that are used to...
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FDA Roundup: January 3, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA issued a notice in the Federal Register with its determination that 35 fo...
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FDA Roundup: December 27, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA announced recommended changes to labeling for transmucosal buprenor...
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FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic ProductsToday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products....
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FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 DiabetesToday, the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indica...
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FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in ExtremitiesThe U.S. Food and Drug Administration approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascu...
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FDA Updates “Healthy” Claim, Providing a Refreshed Tool for ConsumersToday, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of preventable, diet-related c...