HHS to Cut 10,000 Jobs, Veterans Affairs to Layoff 80,000
The Dept of Health and Human Services will slash its full-time federal workforce by 10,000 employees, while the Dept of Veterans Affairs plans to layoff 80,000 workers.
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HHS to Cut 10,000 Jobs, Veterans Affairs to Layoff 80,000
The Dept of Health and Human Services will slash its full-time federal workforce by 10,000 employees, while the Dept of Veterans Affairs plans to layoff 80,000 workers.
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FDA: Do Not Inhale Nitrous Oxide Products
The FDA has issued a public health alert warning consumers not to inhale or recreationally use any flavor of nitrous oxide products being sold in canisters, tanks, or chargers in retail stores.
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Device Correction Issued for Smiths Medical Endotracheal Tubes
Certain Smiths Medical intubation ORAL/NASAL endotracheal tubes may be smaller than expected and could result in inadequate ventilation to the patient, according to an FDA alert.
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FDA Approves Biosimilar Omlyclo for Asthma
Omlyclo (omalizumab-igec) is the first and only biosimilar designated as interchangeable with Xolair (omalizumab) for the treatment of moderate to severe persistent asthma, CRSwNP, IgE-mediated food allergy, and chronic spontaneous urticaria.
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HHS Seeks to End Public Comment Practice
The American public may lose the ability to comment on US Department of Health and Human Services policy decisions, as HHS secretary Robert F. Kennedy Jr. seeks an end to the practice that was established in 1971, according to Reuters.
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FDA, CDC Cancel Flu Vaccine Advisory Meetings
A scheduled meeting of the US FDA’s influenza vaccine advisory board set for March 13 has been canceled, following another postponement by the CDC last week.
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Linde Submits NOxBox I Plus for FDA Clearance
Linde Gas & Equipment Inc has submitted a 510(k) premarket notification to the FDA for its NOxBox I Plus, a nitric oxide delivery and monitoring system.
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FDA Clears Visby Medical Flu + COVID Test
Visby Medical’s handheld PCR test that differentiates between influenza A, B, and COVID-19 received FDA clearance and a CLIA waiver.
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Recall for Certain Phasitron Breathing Circuits from Sentec/Percussionaire
Sentec/Percussionaire is recalling Phasitron breathing circuit kits after receiving a customer complaint that the venturi component of the kit may stop oscillating during use, resulting in patient oxygen desaturation, according to an FDA alert.
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FDA Approves New Class of Non-Opioid Pain Medication
The FDA has approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults, according to the agency.
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Oxygen Concentrator Recalled Due to Risk of Spontaneous Fire
JMC5A Ni/TruAire-5 Oxygen Concentrators have been recalled due to incidents of device melting and fire during use, according to an FDA alert.
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Neo-Tee T-Piece Resuscitators Pulled Over Risk of Inadequate Ventilation
Mercury Medical is removing certain Neo-Tee T-Piece resuscitators from where they’re used or sold after a defect in the device’s controller was found to potentially prevent proper ventilation.
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Federal Health Agencies Ordered to Halt Communications
The Trump Administration has ordered federal health agencies — The Food and Drug Administration, Centers for Disease Control and Prevention, and the National Institutes of Health — to “pause” all publicly issued external communications until February 1, 2025, according to multiple media outlets.
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Judge Halts FDA Rule on Graphic Warning Labels for Cigarettes
The court found merit in claims that the FDA likely exceeded its statutory authority by requiring more warnings than allowed under the Tobacco Control Act.
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CRISPR-TB Blood Test Gets FDA Breakthrough Device Designation
The test uses a molecular diagnostic platform to detect Mycobacterium tuberculosis DNA in blood samples.
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FDA: Label Similarities Between Epinephrine Products Causing Dangerous Confusion
Similarities in bottle and packaging labels between unapproved nasal and FDA-approved injectable epinephrine products make it difficult to distinguish them, risking accidental injections of the nasal solution.
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FDA Proposes Nicotine Cap in Cigarettes
If finalized, the rule would cap nicotine levels in cigarettes and certain other combusted tobacco products at 0.7 milligrams per gram, significantly lower than the average concentration in these products today.
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New Food Allergen Rules Require Sesame Labeling on Packaged Foods
The FASTER Act requires sesame to be labeled as a major food allergen on packaged foods, with FDA resources available to help consumers understand the new labeling requirements.
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Priority Review Granted for Drug Targeting Advanced EGFR-Mutated NSCLC
The treatment, designed for patients with advanced EGFR-mutated NSCLC resistant to prior therapies, could offer a new option pending FDA approval.
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FDA Mandates Guillain-Barré Syndrome Warning for Two RSV Vaccines
The FDA has required Guillain-Barré syndrome warnings to be added to prescribing information for RSV vaccines Abrysvo and Arexvy.
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Draft FDA Guidance Targets Disparities in Pulse Oximeter Performance
The FDA has issued new draft guidance aimed at improving the accuracy and performance of pulse oximeters across different skin tones.
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FDA Grants Orphan Drug Designation to Antibiotic for NTM Infections
The antibiotic shows promising antibacterial activity against common NTM strains, with favorable safety profiles, low resistance potential, and high oral bioavailability.
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Trodelvy, Approved for Breast Cancer, Receives FDA Breakthrough Designation for Lung Cancer
Gilead Sciences’ Trodelvy receives FDA Breakthrough Therapy Designation for the treatment of extensive-stage small cell lung cancer.
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FDA Grants Breakthrough Designation to Sepsis Risk Assessment Test
The FDA has granted Breakthrough Device Designation to a sepsis risk assessment test designed to support rapid clinical decisions.
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