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FDA delivers de novo clearance to Scopio’s bone marrow pathology AI for blood disorders, cancer
FierceBiotech· 1 day agoScopio Labs has received a de novo clearance from the FDA for its artificial intelligence-powered...
FDA Publishes Q&A Guidance on Mandatory Food Recalls
The National Law Review· 1 day agoThe Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to ...
FDA warns of counterfeit Botox: Raleigh providers explain how to avoid dangerous products
WNCN via Yahoo News· 24 hours agoAt Blue Ridge Dermatology, Botox is kept inside a locked refrigerator. The neurotoxin is used...
Heart pumps recalled after reports of 14 deaths, over 270 injuries: FDA
WPIX New York City, NY via Yahoo News· 1 day agoThe FDA announced Monday that two heart pump products are being recalled after reports of 14 deaths...
FDA classifies recall of Boston Scientific device as 'most serious'
Reuters via Yahoo News· 1 day agoAn investigation showed that Boston's device, Obsidio Embolic, when used with a specific technique...
BiVictriX Therapeutics AML treatment granted orphan drug status by FDA
Proactive Investors· 2 days agoBiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) told investors that the US Food and Drug...
FDA Approves Second Ustekinumab Biosimilar
Medscape· 2 days agoThe biosimilar is expected to be marketed in the United States on or after February 21, 2025.
FDA Issues First Warning Letter to Food Importer Under FSVP
The National Law Review· 1 day agoAs our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions ...
FDA recalls implanted heart devices linked to 14 deaths
UPI· 1 day agoAbout 14,000 of the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of...
FDA Sponsors Workshops on the Use of Meta-Analyses in Nutrition Research and Policy
The National Law Review· 22 hours ago© 2024 Keller and Heckman LLP National Law Review, Volumess XIII, Number 256
