FDA Roundup: December 20, 2024

SILVER SPRING, Md., Dec. 20, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  Today, the FDA provided answers to a set of FAQs about software
        functions that may be described as clinical decision support (CDS). The
        FAQs are intended to help sponsors identify whether their CDS software
        may or may not meet the definition of a medical device, as described in
        the FDA's final guidance for Clinical Decision Support Software.
        Additionally, the FDA updated the list of authorized Artificial
        Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices;
        totaling 1,016. The list is not a comprehensive resource of medical
        devices that incorporate AI/ML. The devices in this list have met the
        FDA's applicable premarket requirements.








    --  On Monday, the FDA approved a premarket approval application (PMA)
        180-day supplement for the OraQuick Human Immunodeficiency Virus (HIV)
        Self-Test. This approval represents a labeling change to lower the
        approved age to individuals who are 14 to 17 years of age and older for
        the OraQuick HIV Self-Test to provide access to HIV testing to
        adolescents. The original approval of the OraQuick HIV -Self Test was
        indicated only for individuals who are 17 years and older.This is the
        first approval for an over-the-counter HIV test in adolescents.
        Availability will help in the detection of HIV among the adolescent
        population. The OraQuick HIV Self-Test is a single home-use test to
        detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and
        Type 2 (HIV-2) in human oral fluid specimens. This test kit includes of
        a test stick (device) to collect the specimen, a test tube (vial) to
        insert the test stick (device) and complete the test, testing
        directions, booklet titled, "HIV, Testing and Me", and access to the
        OraQuick Support Center to assist users with questions about performing
        the test, or to connect them with a healthcare provider in their area.
        The OraQuick HIV Self-Test is not intended to be used with specimens
        other than oral fluid. Individuals should obtain a confirmatory test in
        a medical setting.Complete instructions for use can be found on the
        FDA's website here.

    --  On Thursday, the FDA Office of Inspections and Investigations published
        a Viewpoint article titled Partnership in Action: Creating Safeguards
        for Imported Products Entering the United States in the Pacific Islands
        by Dan Solis, Assistant Commissioner for Import Operations. The article
        highlights the FDA's work in Guam to ensure that imported products
        entering the U.S. through the Pacific Rim are safe for consumers. The
        Pacific Rim is a strategically significant location when it comes to
        ensuring the safety of products bound for consumers in the United
        States, as a little more than a third of global products coming into our
        country originate in the Asia-Pacific Region. You can learn more about
        the FDA's efforts in the Pacific Islands by listening to OII Podcasts |
        FDA. The 5-Part series is called, Guam Series: FDA Presence and Impact
        in Pacific Islands.


    --  On Thursday, the FDA updated the outbreak advisory for Salmonella
        Typhimurium infections linked to cucumbers with additional cases. The
        FDA's investigation remains ongoing.


    --  On Thursday, the FDA approved Tryngolza (olezarsen), used with diet, to
        reduce triglycerides (TG) in adults with familial chylomicronemia
        syndrome (FCS). FCS is a rare, genetic disorder that prevents the body
        from breaking down fats (TG) in the bloodstream. People with FCS can
        have TG levels in the thousands. These high TG levels can cause severe
        abdominal pain, inflammation of the pancreas (acute pancreatitis), and
        fatty deposits in the skin (xanthomas). Some of these symptoms,
        specifically acute pancreatitis, can be life-threatening. This is a
        first-in-class approval, meaning Tryngolza uses a new mechanism of
        action, or works differently in the body, than other therapies currently
        used to treat FCS. The most common adverse reactions were injection site
        reactions, decreased platelet count, and arthralgia.


    --  On Thursday, the FDA re-evaluated its determination from October 2,
        2024, on the status of the tirzepatide shortage. The agency issued a new
        decision determining the tirzepatide injection shortage is resolved. The
        FDA's determination is based on its analysis of all the information
        before the agency.


    --  On Wednesday, the FDA posted the latest video in the FDA In Your Day
        series. This one focuses on pertussis, also known as whooping cough, and
        what consumers can do to protect themselves and those around them.


    --  On Wednesday, the FDA approved Ryoncil (remestemcel-L-rknd) an
        allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy,
        for steroid-refractory acute graft versus host disease (SR-aGVHD) in
        pediatric patients 2 months of age and older. Ryoncil is the first
        FDA-approved MSC therapy. The most common nonlaboratory adverse
        reactions (incidence >=20%) were viral infectious disorders, bacterial
        infectious disorders, infection - pathogen unspecified, pyrexia,
        hemorrhage, edema, abdominal pain and hypertension.


    --  On Wednesday, the FDA approved Ensacove (ensartinib, Xcovery Holdings,
        Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive
        locally advanced or metastatic non-small cell lung cancer (NSCLC) who
        have not previously received an ALK-inhibitor. The most common adverse
        reactions (>=20%) were rash, musculoskeletal pain, constipation, cough,
        pruritis, nausea, edema, pyrexia, and fatigue.


    --  On Wednesday, the FDA shared our latest testing results for per- and
        polyfluoroalkyl (PFAS) substances in clams as follow up to the agency's
        findings in the 2022 PFAS in seafood survey. Between October 2022 and
        September 2024, the FDA collected and analyzed 12 samples of processed
        clams with China as the country of origin. All 12 samples had detectable
        levels of at least one type of PFAS.


    --  On Wednesday, the FDA issued a letter to food manufacturers that Amanita
        muscaria (A. muscaria), its extracts, and certain of its constituents
        (muscimol, ibotenic acid, and muscarine) are not authorized for use as
        ingredients in conventional food. A. muscaria and its constituents have
        been used in foods intended to have hallucinogenic effects, sometimes
        marketed as "psychedelic edibles", "legal psychedelics" or "mushroom
        edibles". After reviewing the available information about A. muscaria
        and its constituents, the FDA concluded that they do not meet the safety
        standard for use in food and that their use as food ingredients may be
        harmful. We also recommend that people avoid eating foods with these
        ingredients. The FDA's assessment of chemicals in the food supply is
        part of our commitment to food safety and public health.


    --  On Wednesday, the FDA updated the advisory for the outbreak of E. coli
        illnesses linked to certain sizes and brands of organic whole and baby
        carrots supplied by Grimmway Farms. According to CDC, as of December 18,
        2024, this outbreak is over. The FDA conducted inspections at Grimmway
        Farms and collected environmental samples. Two environmental samples
        collected outside were positive for Shiga toxin-producing E. coli
        (STEC). Although both strains of E. coli detected in the samples are
        capable of causing human illness, neither match the strain of E. coli
        causing illnesses in this outbreak. The FDA is working with Grimmway
        Farms on corrective and preventive actions. The FDA's investigation is
        complete.
    --  On Tuesday, the FDA and the U.S. Department of Agriculture announced a
        charter that details how the two agencies work together to determine the
        appropriate agency to regulate the small number of animal biologicals
        for which jurisdiction may be unclear. Representatives from the FDA and
        USDA originally signed a Memorandum of Understanding in 2013 that
        outlined which animal biologicals each would regulate. Since 2013,
        science has continued to advance, and the jurisdiction of some products
        is not clear under the MOU. The charter includes a flowchart to help
        clarify which agency will regulate a given product, as well as
        information on how to request a jurisdiction determination from the FDA
        and USDA for animal biologicals.

Additional Resources:

    --  FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration