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532 stories matching this filter · ← front page

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  • FDA device center outlines FY 2027 guidance plan, targeting AI-enabled devices and change-control plans
    On Oct 1, the FDA’s Center for Devices and Radiological Health announced its guidance agenda for fiscal year 2027. The top priority is finalizing guidance for artificial intelligence-enabled medic…
    raps · 19d agoRegulatoryNeutral↗ source
  • Stewart’s Shop Corp. Recalls Heavenly Medley and Vanilla-Chocolate-Strawberry Due to Possible Foreign Object
    October 2, 2026, Stewart’s Shops Corp. of Saratoga Springs, NY is recalling two flavors, Heavenly Medley and Vanilla-Chocolate-Strawberry, of half-gallon ice cream due to the potential presence of…
    fda recalls · 18d agoRegulatoryNeutral↗ source
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  • Flowers Foods recalls Nature’s Own Hawaiian Bread after discovering undeclared milk allergen
    Flowers Foods announced on October 2, 2026 that it is pulling its Nature’s Own Hawaiian Bread from the market. The recall covers both the 20‑ounce loaves and the 40‑ounce two‑pack versions sold und…
    fda recalls · 18d agoCRLNegative↗ source
  • EAK Distribution recalls Home Grown broccoli seed packets over possible Salmonella contamination
    EAK Distribution LLC announced on October 2, 2026 that it is recalling its 8‑oz Home Grown Green Sprouting Calabrese Broccoli Seeds due to a potential Salmonella contamination. The company warned…
    fda recalls · 18d agoRegulatoryNegative↗ source
  • Frutas y Hortalizas del Sur expands recall to more Great Value and Trader Joe's frozen berry products over E. coli risk
    Frutas y Hortalizas del Sur S.A., a Chilean producer, announced on Oct 2, 2026 that it is expanding its earlier recalls of frozen organic berries. The expansion adds additional lots of Great Value…
    fda recalls · 18d agoCRLNeutral↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    On Oct 1, 2026 the U.S. Department of Health and Human Services announced a new initiative under the Advanced Research Projects Agency for Health. The initiative, named the Simulation-augmented, R…
    raps · 20d agoRegulatoryNeutral↗ source
  • EU Council adopts new pharma package to modernize drug legislation
    The Council of the European Union has approved a comprehensive "pharma package" of rules aimed at updating the regulatory framework for medicines across the bloc. The new legislation seeks to stre…
    raps · 20d agoRegulatoryNeutral↗ source
  • ICMRA urges cut to animal testing while HHS launches ARPA-H SURPASS program to accelerate clinical trials
    International Coalition of Medicines Regulatory Authorities released a joint statement urging drug makers and national control labs to cut back on animal testing throughout a medicine’s development…
    raps · 20d agoRegulatoryNeutral↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    The U.S. Department of Health and Human Services announced a new initiative under ARPA-H called the Simulation‑augmented, Real‑time Platform Adaptive Seamless Trials (SURPASS) program. SURPASS is…
    raps · 20d agoRegulatoryPositive↗ source
  • Greenwich Rx voluntarily recalls compounded glutathione injections over possible elevated endotoxin levels
    Greenwich Rx, a 503A compounding pharmacy based in Tomball, Texas, announced a voluntary nationwide recall of specific lots of its compounded glutathione injection product. The recall is being issu…
    fda recalls · 19d agoCRLNegative↗ source
  • Saint Francis Apizza recalls frozen pizzas over undeclared soy allergen
    Saint Francis Apizza LLC announced a voluntary recall of several frozen pizza varieties because soy allergen was not listed on the label. The affected products include Pepperoni, Plain Cheese, Sup…
    fda recalls · 19d agoCRLNegative↗ source
  • Gias Foods recalls Bettergoods Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of all lot codes of its Bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated possible contamination with Listeria monocyt…
    fda recalls · 19d agoRegulatoryNegative↗ source
  • WinCo Foods recalls salsa bean dip trays after recalled peperoncini found in ingredient
    WinCo Foods of Boise, Idaho announced a recall of its ready‑made salsa bean dip trays after learning that the product contains peperoncini from G.L. Mezzetta that had been recalled. The recall cov…
    fda recalls · 19d agoRegulatoryNegative↗ source
  • FDA seeks new advisory committee members, signaling renewed focus on external expertise
    The FDA announced it is inviting subject‑matter experts and consumer representatives to serve on its advisory committees. The call follows a period when the advisory committees had a reduced role…
    raps · 21d agoRegulatoryNeutral↗ source
  • Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules
    Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…
    raps · 21d agoRegulatoryNeutral↗ source
  • FDA approves Egetis’ Emcitate for rare genetic disease as Novo secures Chinese weight-loss pill in $2.6 billion deal
    The U.S. Food and Drug Administration has granted approval to Egetis' Emcitate, a therapy targeting a rare genetic disorder. This marks a regulatory milestone for the company and patients awaiting…
    raps · 22d agoDealPositive↗ source
  • Regulators Discuss Plans to Streamline Europe’s Drug Approval Process at 2026 RAPS Convergence
    A panel of European regulators gathered at the 2026 RAPS Convergence in Charlotte, North Carolina to discuss ongoing initiatives aimed at simplifying the continent’s regulatory framework. The offi…
    raps · 22d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on requirements for robotically assisted surgical devices
    The FDA has published a draft guidance outlining its thinking on the requirements for bringing certain robotically assisted surgical devices to market. The guidance describes both non-clinical and…
    raps · 22d agoRegulatoryNeutral↗ source
  • FDA proposes new BsUFA IV commitment letter to streamline biosimilar reviews
    The U.S. Food and Drug Administration released a draft commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, highlighting several departures from the existing biosimilar review fram…
    raps · 23d agoRegulatoryNeutral↗ source
  • FDA CDER chief says expanding generic GLP-1 drugs is top priority to cut American costs
    Michael Davis, director of the FDA's Center for Drug Evaluation and Research, highlighted that increasing the supply of generic GLP-1 medicines is a key focus for the agency. He noted that broader…
    raps · 23d agoRegulatoryNeutral↗ source
  • FDA offers guidance for smoother BLA submissions and outlines biosimilar review changes
    Submitting a biologics license application requires early interaction with the FDA's Office of Therapeutic Products, careful preparation to avoid technical and administrative mistakes, and keeping…
    raps · 23d agoRegulatoryNeutral↗ source
  • FDA advises early engagement and error prevention for BLA submissions, says CBER expert
    A CBER specialist shared practical guidance for companies preparing biologics license applications. The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can str…
    raps · 23d agoRegulatoryNeutral↗ source
  • Indian government approves monitoring plan for adverse events in organ and tissue transplantation products
    The Indian government has given formal approval to a new program that will track adverse events linked to medicines and biologics used in organ and tissue transplantation. The initiative is design…
    raps · 23d agoRegulatoryNeutral↗ source
  • Sierra Nevada Cheese Company recalls all Graziers raw milk cheeses over possible E. coli O26:H11 contamination
    Sierra Nevada Cheese Company of Willows, California, announced a voluntary recall of its Graziers Raw Milk Cheese line, which includes Monterey Jack, Jalapeno Jack, Medium Cheddar and Sharp Cheddar…
    fda recalls · 22d agoNegative↗ source
  • Mezzetta voluntarily recalls 32-oz Golden Greek Peperoncini after pest contaminant found in jar
    G. L. Mezzetta Inc. announced a voluntary recall of its 32‑oz Golden Greek Peperoncini after a video showed a pest contaminant in a jar. The recall is limited to lot 720106 (SKU 10106328). The com…
    fda recalls · 24d agoRegulatoryNeutral↗ source