Abbott is addressing a critical issue affecting certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus…
Category: US
US / FDA updates on medical device regulation and quality.
Live it Up Super Greens Recalled Over Potential Salmonella Contamination
Superfoods Inc., operating under the name Live it Up, has issued a voluntary recall for its…
FDA Warns of Dislodged Deaeration Chambers in Vantive Prismaflex Dialysis Tubing Sets
The FDA has issued an early alert regarding a critical issue with certain Vantive Prismaflex dialysis…
Spring & Mulberry Recalls Mint Leaf Date Sweetened Chocolate Bars Over Salmonella Concerns
Spring & Mulberry Issues Recall of Mint Leaf Chocolate Bars Over Potential Salmonella Contamination On January…
FDA Draft Guidance Advances Use of Bayesian Methods in Clinical Trials
The U.S. Food and Drug Administration (FDA) has issued new draft guidance aimed at streamlining clinical…
FDA Authorizes First Pediatric Treatment for Rare Menkes Disease
The U.S. Food and Drug Administration (FDA) has approved Zycubo (copper histidinate) injection, marking a significant…
FDA Grants National Priority Voucher to New Treatment for Multiple Myeloma Following Phase 3 Success
The U.S. Food and Drug Administration (FDA) has awarded a national priority voucher for teclistamab in…
FDA Removes Key Restriction on Real-World Evidence in Drug and Device Applications
The U.S. Food and Drug Administration (FDA) announced a significant regulatory update on January 12, 2026,…
FDA Strengthens Recall Processes After Infant Botulism Cases Linked to ByHeart Formula
The U.S. Food and Drug Administration (FDA) has announced plans to enhance the effectiveness of food…
FDA Seeks Venture Capital Input to Reform Contracting for Public Health Innovation
The U.S. Food and Drug Administration (FDA) is exploring new avenues for collaboration with America’s top…