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624 stories matching this filter · ← front page

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  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 3mo agoCRLNegative↗ source
  • FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
    The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version. The problem involves possibl…
    fda medwatch · 3mo agoCRLNegative↗ source
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  • Sunny Pharmtech voluntarily recalls three lots of cyclophosphamide injection after steel particles found
    Sunny Pharmtech, Inc. announced a voluntary nationwide recall of three lots of cyclophosphamide for injection, USP, in 1‑gram and 2‑gram vials. The recall was triggered by the detection of steel pa…
    fda medwatch · 3mo agoCRLNeutral↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 3mo agoCRLNegative↗ source
  • Lidl US recalls Eridanous shortbread cookies over undeclared wheat, soy, milk, and egg allergens
    Lidl US announced a recall of its Eridanous Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling, 11.6 oz boxes, after discovering that the packaging was in a foreign language and om…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • Most FDA-approved drugs meet postmarketing study requirements, and advisory panel backs two peptides for bulk compounding
    A recent analysis published in JAMA Network Open found that nearly nine out of ten drugs approved by the U.S. Food and Drug Administration have completed their postmarketing requirements or commitm…
    raps · 3mo agoRegulatoryNeutral↗ source
  • J&J gets FDA clearance for general surgery robot; study finds 90% of approved drugs meet post-marketing commitments
    J&J received FDA authorization for a general‑surgery robot, a notable regulatory step for the company. The FDA is also being urged to ban direct‑to‑consumer drug advertisements, highlighting ongoi…
    raps · 3mo agoRegulatoryNeutral↗ source
  • EMA seeks input on draft revisions to biosimilar efficacy guidance
    The European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding list
    The FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ul…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Midwest Poultry Services recalls over 1.5 million dozen eggs over possible Salmonella Enteritidis contamination
    Midwest Poultry Services, L.P. announced a voluntary recall of 1,589,577 dozen white and brown cage-free shell eggs produced in Texas. The recall was triggered by a potential contamination with Sa…
    fda recalls · 3mo agoCRLNegative↗ source
  • FDA sends warning letters to Sanofi and Viatris over misleading product claims
    The FDA’s Office of Prescription Drug Promotion issued untitled warning letters to Sanofi and Viatris after reviewing promotional materials that the agency deemed misleading. The letters cite spec…
    raps · 3mo agoRegulatoryNegative↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 3mo agoNeutral↗ source
  • FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines
    The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
    raps · 3mo agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 3mo agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 3mo agoRegulatoryNeutral↗ source
  • PT Organics recalls select Pumpkin Tree banana‑strawberry puree pouches over possible soft plastic contamination
    PT Organics Limited of Lake Oswego, Oregon announced a voluntary recall of certain Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree pouches. The recall is due to an internal pack…
    fda recalls · 3mo agoCRLNeutral↗ source
  • Fresh & Ready Foods recalls Spicy Breakfast Burritos over undeclared soy
    Fresh & Ready Foods LLC announced a recall of its Sprig & Sprout and Fresh and Ready Spicy Breakfast Burritos because they may contain undeclared soy. The problem was traced to inadvertent inclusi…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • Baxter alerts users to potential air bubble risk in Duo-Vent IV solution sets
    The FDA’s Center for Devices and Radiological Health has issued an early alert about a possible high-risk issue with Baxter’s Duo-Vent intravenous solution sets. The devices may contain air bubbles…
    fda medwatch · 3mo agoRegulatoryNegative↗ source
  • UK regulator reports rise in drug approvals and new AI healthcare regulations
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines in the past year…
    raps · 3mo agoRegulatoryPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 3mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps to regulate AI in healthcare
    The Medicines and Healthcare products Regulatory Agency (MHRA) presented its 2025-2026 annual report to Parliament, highlighting a higher number of new drug approvals compared with the previous yea…
    raps · 3mo agoRegulatoryPositive↗ source
  • Unique Pharma recalls 5 mg cetirizine tablets over possible ranitidine contamination
    Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., announced a voluntary nationwide recall of four lots of its 5 mg cetirizine hydrochloride tablets. The reca…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 3mo agoRegulatoryNeutral↗ source