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685 stories matching this filter · ← front page

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  • Becton Dickinson recalls intraosseous needle sets over risk of obturator removal difficulty
    Becton Dickinson has issued a recall for specific intraosseous vascular access system needle sets after discovering that the obturator (stylet) can be difficult to remove once the device is placed.…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Experts suggest new safety framework to boost predictability of CNS toxicity assessments
    A recent paper outlines a safety framework intended to make central nervous system (CNS) toxicity predictions more reliable during drug development. The authors argue that new approach methodologi…
    raps · 2mo agoNeutral↗ source
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fda medwatch112
globenewswire health73
fda press59
1818
Psychiatry & CNS1212
Ophthalmology1074
Endocrinology & Metabolism782
Pain780
Nephrology764
  • Saudi FDA launches program to accelerate rare-disease drug development
    The Saudi Food and Drug Authority (SFDA) announced a new initiative called the New Accelerator Program for Drugs in Rare Diseases (NADR). The program is designed to speed up the development, evalu…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Oma's Pride recalls one lot of 6 lb Woof Complete canine chicken food after Salmonella contamination
    Oma's Pride of Avon, Connecticut, announced a voluntary recall of a single lot (BB012729) of its 6‑lb Woof Complete Canine Chicken Recipe pet food after testing revealed Salmonella contamination.…
    fda recalls · 2mo agoCRLNeutral↗ source
  • Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidance
    Industry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with pay…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA issues final guidance on formal meeting types and timelines for drug and biologics sponsors
    The U.S. Food and Drug Administration released final guidance on August 13 that details the types of formal meetings sponsors can request during the development of new drugs and biologics. The doc…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips for possible undeclared gluten
    Exotique Foods Inc of Ontario announced a recall of its Momchipz Veggie Chips in the broccoli florets and cauliflower flavor because the product may contain undeclared gluten. The chips, sold in 3…
    fda recalls · 3mo agoCRLNegative↗ source
  • FDA releases weekly update on user fee letters and new HHS regulatory agenda
    The FDA's latest weekly briefing highlighted the release of user fee commitment letters, which outline the agency's financial planning for upcoming fiscal periods. It also introduced a new regulat…
    raps · 3mo agoRegulatoryNeutral↗ source
  • The Hampton Grocers recalls 8-oz Lacnola Lactation Granola over possible Salmonella contamination
    The company announced a recall of its 8-oz Lacnola Lactation Granola due to potential Salmonella contamination. The product was sold nationwide through the company's website and other online retai…
    fda recalls · 2mo agoRegulatoryNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips over undeclared wheat risk
    Exotique Foods Inc announced a recall of its Momchipz Veggie Chips Broccoli Florets & Cauliflower because the product may contain undeclared wheat, posing a serious allergy risk. The chips, sold t…
    fda recalls · 3mo agoCRLNegative↗ source
  • FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in China
    The U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Baxter recalls Duo-Vent IV solution sets over risk of air bubbles in patients
    Baxter has issued a recall of its Duo-Vent solution sets and male Luer lock adapters after the FDA identified a risk that the devices could contain air bubbles in the drip chamber and tubing. The…
    fda medwatch · 3mo agoCRLNegative↗ source
  • European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversight
    A trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database. The group says that such access would enable them to apply the risk-…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA releases draft PDUFA VIII commitment letter outlining goals and enhancements for 2028-2032
    The FDA on Thursday issued a proposed commitment letter for the upcoming PDUFA VIII cycle, which will cover fiscal years 2028 through 2032. The letter sets out the agency's performance targets for…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA grants emergency use authorization for Simparica TRIO to treat New World screwworm in dogs and puppies
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Simparica TRIO, a chewable tablet containing sarolaner, moxidectin and pyrantel, to treat New World screwworm infesta…
    fda press · 3mo agoRegulatoryPositive↗ source
  • Grand Central Bakery recalls potato sourdough loaves over possible metal fragments
    Grand Central Bakery of Seattle announced a recall of its potato sourdough bread after discovering that some loaves may contain pieces of metal. The recall includes 20‑oz, 12‑oz and other sized lo…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • Grand Central Bakery recalls Potato Sourdough loaves over possible metal contamination
    Grand Central Bakery of Seattle announced a recall of its Potato Sourdough bread after discovering that some loaves might contain metal fragments. The recall covers loaves sold on August 10, 2026…
    fda recalls · 3mo agoNegative↗ source
  • Medline issues correction for convenience kits containing recalled ICU Medical pain management components
    Medline announced a correction for certain convenience kits that include ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified…
    fda medwatch · 3mo agoCRLNegative↗ source
  • FDA issues early alert on non-sterile BD ChloraPrep applicators in Medline convenience kits
    The FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators th…
    fda medwatch · 3mo agoRegulatoryNeutral↗ source
  • Hardie’s Fresh Foods recalls 5‑lb pepper jalapenos over potential Salmonella contamination
    Dairyland Produce, operating as Hardie’s Fresh Foods in Houston and Dallas, announced a recall of its 5‑pound pepper jalapeno product due to possible Salmonella contamination. The recall affects j…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • FDA releases proposed commitment letter detailing changes to GDUFA IV program
    The U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV). The letter follows several months o…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Kettle Cuisine recalls Marketside Tomato Bisque Soup Kit sold at Walmart over possible Listeria contamination
    Kettle Cuisine LLC announced a recall of its 14‑oz Marketside Tomato Bisque Soup Kit after discovering a potential contamination with Listeria monocytogenes. Listeria can cause severe illness, esp…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • Oma's Pride recalls one lot of Woof Complete Canine Chicken Recipe due to possible Salmonella contamination
    Oma's Pride of Avon, Connecticut announced a voluntary recall of a single lot (BB012729) of its 6‑lb Woof Complete Canine Chicken Recipe pet food after testing identified Salmonella contamination.…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • Whole Foods recalls dips, salsas and other prepared foods containing jalapeños over possible Salmonella risk
    Whole Foods Market announced a recall of select produce and prepared-food items that contain jalapeños supplied by Coast Citrus Distributors because of a potential Salmonella contamination. The re…
    fda recalls · 3mo agoCRLNegative↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 3mo agoCRLNegative↗ source