Tag: U.S. Food and Drug Administration

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FDA Warns on Contaminated Tattoo Ink

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the staff of the Ridgewood blog

Twp. of Washington NJ, the U.S. Food and Drug Administration is warning consumers, tattoo artists, and retailers about the risk of serious infections associated with tattoo inks contaminated by harmful bacteria, including Pseudomonas aeruginosa. Tattoo inks that are contaminated can cause infections and lead to severe health issues when injected into the skin during a tattooing procedure, as there is an increased risk of infection whenever the skin barrier is breached.

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US to Phase Out all Petroleum-based Synthetic Dyes from the Nation’s Food Supply

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the staff of the Ridgewood blog

Washington DC, the U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader initiative to Make America Healthy Again.

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FDA Approves Updated mRNA COVID-19 Vaccines for Currently Circulating Variants

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the staff of the Ridgewood blog

Ridgewood NJ, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

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FDA Approves Alzheimer’s Drug Leqembi , Slowed Cognitive Decline in Clinical Trial

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the staff of the Ridgewood blog

Washington DC,  the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease.

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FDA says lab-grown meat is safe for human consumption

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gives new meaning to the term mystery meat 

the staff of the Ridgewood blog

Washington DC, the world is experiencing a food revolution and the U.S. Food and Drug Administration is committed to supporting innovation in the food supply. As an example of that commitment, today we are announcing that we have completed our first pre-market consultation of a human food made from cultured animal cells.

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Recall Announced for Jars of Skippy Peanut Butter

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Recall Announced for a Limited Number of Jars of Skippy® Reduced Fat Creamy Peanut Butter Spread, Skippy® Reduced Fat Chunky Peanut Butter Spread and Skippy® Creamy Peanut Butter Blended with Plant Protein

the staff of the Ridgewood blog

Ridgewood NJ, Skippy Foods, LLC is voluntarily recalling 9,353 cases, or 161,692 total pounds, of a limited number of code dates of SKIPPY® Reduced Fat Creamy Peanut Butter Spread, SKIPPY® Reduced Fat Chunky Peanut Butter Spread and SKIPPY® Creamy Peanut Butter Blended With Plant Protein due to the possibility that a limited number of jars may contain a small fragment of stainless steel from a piece of manufacturing equipment. The code date is located on top of the lid. A photo of the products and “Best If Used By” dates appear below. There have been no consumer complaints associated with this recall to date, and all retailers that received the affected product have been properly notified.

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U.K.’s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Adults 

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Applications Remain Under Review by Other Regulatory Authorities, Including U.S. Food and Drug Administration and the European Medicines Agency

the staff of the Ridgewood blog

KENILWORTH NJ, Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. In the U.K., LAGEVRIO® (lah-GEV-ree-oh) is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. Merck announced its application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application. Merck is actively working to submit applications to other regulatory agencies around the world.

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FDA Gives Full Approval to Pfizer’s COVID-19 Vaccine

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the staff of the Ridgewood blog

Washington DC, today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

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FDA and CDC lifts pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine

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the staff of the Ridgewood blog

Washington DC, Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.

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FDA Issues Emergency Use Authorization for Johnson & Johnson Sigle Dose COVID Vaccine

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the staff of the Ridgewood blog

Washington DC, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

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U.S. Food and Drug Administration Grants Emergency Use Authorization for Eli Lilly COVID Antibody Drug

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the staff of the Ridgewood blog

INDIANAPOLIS  IN, The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.

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FDA Sends Warning on False Positive COVID Test Results

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the staff of the Ridgewood blog

Franklin Lakes NJ, The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic.  A Letter to Clinical Laboratory Staff and Health Care Providers alerting them of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.

In one study, the manufacturer found approximately three percent (3%) of results were false positive results. The FDA is working with Becton, Dickinson and Company (BD) to resolve this issue and will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed for new or additional information.

 

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Red Cross Seeks Recovered COVID 19 Virus Patients for Blood Donations

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the staff of the Ridgewood blog

Ridgewood NJ,The American Red Cross, in coordination with the U.S. Food and Drug Administration, is seeking residents from Morris County and across the state who are fully recovered from the new coronavirus to sign up to donate plasma to help current COVID-19 patients.

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FDA Sweeps Aside Regulatory Barriers to Speed Production of Crucial Medical Products, Including Ventilators

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the staff of the Ridgewood blog

Washington DC, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.

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Fear of Coronavirus is Severely Impacting the U.S. Blood Supply

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the staff of the Ridgewood blog

Montvale NJ, The fear of coronavirus is severely impacting the U.S. blood supply as Vitalant and other blood centers across the country are struggling to maintain stable inventories and avoid a critical blood shortage. With school closures and business shutdowns, 25% of Vitalant’s blood collections anticipated in March have disappeared—almost overnight. And that number continues to grow.

“We need people to start turning out in force to give blood,” said Peter Marks, M.D., Ph.D., director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (the agency that regulates all U.S. blood centers). “We need it not to get to the point that surgeries are having to get canceled.”

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