FDA Roundup: March 11, 2025

SILVER SPRING, Md., March 11, 2025 /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 published a General Correspondence Letter issued to
        Mid-Link Technology Testing Co., Ltd. The FDA is vigilant in ensuring
        data submitted to the FDA can be relied upon to assess the
        effectiveness, safety, or risk of a device. The FDA has noted an
        increase in unreliable testing data from certain third-party testing
        labs. This has resulted in the FDA being unable to reach a substantial
        equivalence determination or otherwise authorize marketing for medical
        devices whose submissions rely on such data. Based on data analysis, the
        FDA determined that Mid-Link Technology Testing Co., Ltd., has in
        several instances, copied the results of another study or created
        falsified or otherwise invalid data that was submitted to the FDA. Until
        the firm adequately addresses these issues, all study data from all
        studies conducted at this testing facility will be rejected. Sponsors of
        device studies and manufacturers of devices are reminded to carefully
        evaluate the third parties they engage to conduct safety, performance,
        and cybersecurity testing and to independently verify all testing
        results before submitting to the FDA. The FDA remains committed to
        taking appropriate actions to address ongoing data integrity concerns.
    --  Today, the FDA posted six warning letters to companies responsible for
        introducing unapproved fat dissolving injectable drug products into
        interstate commerce. The agency reminds consumers that fat-dissolving
        injections that are not FDA approved can be harmful. The letters were
        sent to:
        --  Amazon.com, Inc.
        --  Fox Pharma LLC
        --  Filler Lux dba Filler Lux USA
        --  Hyaluron Pen Store, LLC dba Glow Nest Beauty
        --  Julian Naya Beauty LLC


        --  Vivid-Scientific LLC
    --  On Friday, the FDA approved Omlyclo (omalizumab-igec) injection, for
        subcutaneous use to treat certain allergic, inflammatory, and autoimmune
        conditions. This is the first interchangeable biosimilar to Xolair
        (omalizumab). Omlyclo works by binding to immunoglobulin E (IgE), the
        antibody type that triggers allergic reactions, and blocks IgE from
        binding to its receptors. Omlyclo is administered subcutaneously for all
        indications but has different dosing instructions for each indication.
        More information about Omlyclo can be found in the full prescribing
        information.

Additional Resources:

    --  FDA Newsroom

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