FDA Roundup: April 19, 2024

SILVER SPRING, Md., April 19, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  On Thursday, the FDA posted a safety communication to inform the public
        and healthcare providers that the agency has required and approved
        labeling changes to the U.S. Prescribing Information (USPI) for all
        licensed BCMA-directed and CD19-directed genetically modified autologous
        CAR-T cell immunotherapies.These completed changes follow a safety
        communication posted by the FDA in November 2023, and reflect
        requirements detailed in notification letters issued by the FDA in
        January 2024, to all manufacturers of the products in this class
        necessitating an update to the Boxed Warning on the package insert to
        include new safety information on the serious risk of T cell
        malignancies, with serious outcomes, including hospitalization and
        death. The FDA also required related safety labeling changes to other
        sections of the USPI: Warnings and Precautions, Postmarketing
        Experience, Patient Counseling Information and Medication Guide.


    --  On Thursday, the FDA approved alectinib (Alecensa, Genentech, Inc.) for
        adjuvant treatment following tumor resection in patients with anaplastic
        lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as
        detected by an FDA-approved test. Full prescribing information for
        Alecensa will be posted here.


    --  On Thursday, the FDA shared updates on agency activities to better
        understand Per- and Polyfluoroalkyl Substances (PFAS) in the food
        supply, including testing results, continuing efforts to supplement our
        PFAS monitoring, and an updated analytical method to measure PFAS.




    --  On Wednesday, the FDA's Center for Devices and Radiological Health
        Center (CDRH) released two reports on medical device safety and
        innovation -core pillars that help protect and promote public health for
        all. The "CDRH 2024 Safety Report" and the "CDRH 2024 Innovation Report"
        provide summaries of CDRH's accomplishments and look ahead to future
        initiatives."Our focus on safety and innovation stems from our vision to
        protect and promote the public health by helping to assure that medical
        devices on the U.S. market are high-quality, safe and effective, and
        that patients and providers have timely and continued access to these
        devices," said CDRH Director Dr. Jeff Shuren.


    --  On Wednesday, the FDA issued an outbreak advisory for a multistate
        outbreak of Salmonella Typhimurium infections linked to Infinite
        Herbs-brand organic basil packed in 2.5-oz clamshell packaging and sold
        at Trader Joe's stores in AL, CT, D.C., DE, FL, GA, IA, IL, IN, KS, KY,
        MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, PA, RI, SC, TN, VA, VT,
        and WI. Typhimurium infections linked to Infinite Herbs-brand organic
        basil packed in 2.5-oz clamshell packaging and sold at Trader Joe's
        stores in AL, CT, D.C., DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI,
        MN, MO, NC, NE, NH, NJ, NY, OH, PA, RI, SC, TN, VA, VT, and WI.


    --  On Wednesday, the FDA approved Lumicell Inc.'s Direct Visualization
        System, a combination product that is the first fluorescent imaging
        system to assist in the detection of cancerous tissue within the
        lumpectomy cavity following the removal of the primary specimen during
        breast conserving surgery. This product consists of an optical imaging
        agent Lumisight (the drug pegulicianine) that is administered to the
        patient via intravenous injection two to six hours before imaging and a
        fluorescence imaging system designed to capture emissions from the
        optical imaging agent.


    --  On Wednesday, the FDA also approved Lumisight (pegulicianine) in adults
        with breast cancer to assist the intraoperative detection of cancerous
        tissue within the resection cavity following removal of the primary
        specimen during lumpectomy surgery. Lumisight is a fluorescent imaging
        drug for use with the Lumicell Inc.'s Direct Visualization System that
        is administered in the form of an intravenous injection before surgery.


    --  On Tuesday, Nature Medicine published a new commentary co-authored by
        the FDA's Center for Tobacco Products Director Brian King, Ph.D.,
        M.P.H., discussing considerations for healthcare providers around
        talking to adults about the relative risks of different tobacco
        products. The commentary reinforces that youth should not use any form
        of tobacco products. Among adults who smoke, it stresses the importance
        of using evidence-based cessation methods, including FDA-approved
        pharmacotherapies, as a first line treatment. For adults who smoke and
        have tried proven cessation methods with no success, medical providers
        may consider educating patients about the relative risks of tobacco
        products and the importance of switching completely to a lower-risk
        product in order to realize the full health benefit, and of not engaging
        in prolonged use of both products. In conjunction with this release, the
        FDA launched a new webpage aimed at educating the public about the
        relative risks of tobacco products.


    --  On Tuesday, the FDA launched a new post-incident response web page about
        elevated lead levels in cinnamon, focused on post-incident surveillance,
        prevention, and compliance activities.
    --  On Monday, the FDA issued marketing denial orders (MDOs) to Shenzhen
        Yibo Technology Co. Ltd. for 65 disposable e-cigarettes marketed as
        "MNGO Disposable Stick." As a result, the company must not market or
        distribute these products in the United States or they risk FDA
        enforcement action.

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