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528 stories matching this filter · ← front page

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  • Brad's Raw Chips recalls kale chips over potential thallium contamination
    Snack Right Super Foods, doing business as Brad's Raw Chips, announced a recall of certain Brad's Plant Based Crunchy Kale (2 oz) and Brad's Veggie Chips Kale (3 oz) products because they may conta…
    fda recalls · 11d agoCRLNegative↗ source
  • MedWatch Alert: FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars
    Consumers Should Not Buy or Serve Once Upon a Farm Tractor Wheels, Organic Toddler Soft-Baked Bars Due to a Potentially Fatal Choking Hazard
    fda medwatch · 12d ago↗ source
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FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
fda press · 14d agoApprovalPositive↗ source
  • Instrumentation Laboratories recalls several lots of HemosIL AcuStar HIT-IgG(PF4-H) assay due to false-negative risk
    Instrumentation Laboratories (Werfen) has issued a recall of specific lots of its HemosIL AcuStar HIT-IgG(PF4-H) radioimmunoassay after the FDA identified a performance issue that could produce fal…
    fda medwatch · 15d agoCRLNegative↗ source
  • Nova Biomedical issues safety instructions for StatStrip Glucose Hospital Meter Gen 2.0
    Nova Biomedical has sent a letter to customers using the StatStrip Glucose Hospital Meter System Gen 2.0, advising updated use instructions while a software fix is prepared. The FDA classified the…
    fda medwatch · 15d agoCRLNegative↗ source
  • FDA rolls out new inspection coordination plan, lifts estradiol patch warning and HHS permits compounding of six peptides
    FDA's drug center and inspections office have agreed on a new concept of operations (ConOps) to better coordinate inspections and compliance activities. A U.S. senator introduced draft legislation…
    raps · 15d agoRegulatoryNeutral↗ source
  • Vitality Works recalls 365 Whole Foods Ashwagandha capsules over possible Salmonella contamination
    Vitality Works Inc., based in Albuquerque, NM, announced a recall of one lot of its 365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha capsules, 120-count, due to potential Salmo…
    fda recalls · 15d agoRegulatoryNegative↗ source
  • Once Upon a Farm recalls all Tractor Wheels toddler bars over choking risk
    Once Upon a Farm announced a recall of every lot and variety of its Tractor Wheels Organic Toddler Soft-Baked bars. The company said the snack can quickly turn into a dense, dry and sticky mass whe…
    fda recalls · 14d agoCRLNegative↗ source
  • FDA approves Stada's Lucentis biosimilar; Lilly claims its triple-G candidate outperforms Ozempic in diabetes
    The U.S. Food and Drug Administration has granted approval for Stada's biosimilar version of Lucentis, expanding treatment options for eye diseases. Lilly announced that its experimental "triple‑G…
    raps · 16d agoApprovalPositive↗ source
  • EMA and African regulator issue joint guidance to accelerate Ebola vaccine trials
    The European Medicines Agency and its African counterpart have released a joint position paper aimed at facilitating Ebola vaccine research. The guidance is intended to help launch clinical trials…
    raps · 16d agoRegulatoryPositive↗ source
  • Medline orders removal of all brand beds and accessories over fire and asphyxiation hazards
    Medline has issued an urgent field safety notice indicating that all of its branded hospital beds and related components must be removed or corrected because of identified safety risks. The FDA’s…
    fda medwatch · 16d agoRegulatoryNegative↗ source
  • HHS issues interim policy allowing compounding of six unapproved peptides under set conditions
    HHS announced an interim policy that will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug su…
    raps · 16d agoRegulatoryNeutral↗ source
  • FDA issues revised draft guidance for drug-device combination product performance
    The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…
    raps · 16d agoRegulatoryNeutral↗ source
  • SLR Food Distribution recalls Wise Wife ground cinnamon over possible lead contamination
    SLR Food Distribution Inc., based in Hicksville, New York, announced a voluntary recall of its Wise Wife brand ground cinnamon. The recall was issued because the product may be contaminated with e…
    fda recalls · 15d agoRegulatoryNegative↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 18d agoRegulatoryNeutral↗ source
  • FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue. The problem is trace…
    fda medwatch · 18d agoCRLNegative↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 18d agoRegulatoryNeutral↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 18d agoRegulatoryNeutral↗ source
  • Taylor Farms recalls H-EB Backyard BBQ Chop Salad Kit over possible undeclared soy and almonds
    Taylor Farms of Dallas, Texas announced a recall of the H-EB Backyard BBQ Chop Salad Kit because the product may contain undeclared soy and tree nuts (almonds). The kits were distributed to H-EB…
    fda recalls · 17d agoCRLNegative↗ source
  • Haifa Smoked Fish recalls 560 lbs of cold-smoked sprats over possible Clostridium botulinum contamination
    Haifa Smoked Fish of Queens, NY announced a recall of about 560 pounds of its cold-smoked sprats after testing indicated possible contamination with Clostridium botulinum, a bacterium that can caus…
    fda recalls · 18d agoRegulatoryNegative↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 19d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 19d agoApprovalNeutral↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 19d agoRegulatoryNeutral↗ source
  • Tonight We Ride recalls Ultimate Forza male supplement after finding undeclared sildenafil, tadalafil and dapoxetine
    Tonight We Ride, LLC of Lakeville, Minnesota announced a voluntary recall of its Ultimate Forza male supplement capsules. The recall was triggered after testing revealed the product contains undec…
    fda recalls · 20d agoCRLNegative↗ source