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    Category: US National Health Agency Sources

    Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

    This is the Draft Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and C…
    fda-agency-news
    fda-agency-news February 19, 2025

    Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

    This is the Draft Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and C…
    fda-agency-news
    fda-agency-news February 19, 2025

    eSubmitter Application History

    History of all updates to the application software in reverse chronological order by version number
    fda-agency-news
    fda-agency-news February 19, 2025

    ZB Importing Issue Voluntary Recall and Allergy Alert on Undeclared Egg, Wheat and Milk in Certain Ulker Brand Products

    ZB Importing LLC is voluntarily recalling certain lots of six varieties of Ulker Brand snack rolls, biscuits, and wafers due to undeclared wheat, egg …
    fda-agency-news
    fda-agency-news February 18, 2025

    Naturipe Value Added Fresh LLC Issues Allergy Alert On Undeclared Wheat & Eggs In “Berry Buddies, Berries & Pancakes” Lot # 1097901

    Naturipe Value Added Fresh LLC. of Alma, GA, is recalling its 2.1 oz./60 gram packages of "Berry Buddies, Berries & Pancakes" bento box snack packs be…
    fda-agency-news
    fda-agency-news February 18, 2025

    Mauna Loa Macadamia Nut Company, LLC Issues a Product Recall on Undeclared Almonds in Mauna Loa Milk Chocolate Covered Macadamias (1oz) Pouches

    Mauna Loa Macadamia Nut Company LLC of Kea’au, HI is voluntarily recalling one batch of its Mauna Loa Milk Chocolate Covered Macadamias snack (1oz) …
    fda-agency-news
    fda-agency-news February 15, 2025

    JE Bakery 2019 LLC DBA Broadway Bakery Issues Allergy Alert for Mislabeled Raisin Bran Muffin 6 Count Due to Undeclared Walnuts

    JE Bakery 2019, LLC, Minneapolis MN is voluntarily recalling its Raisin Bran Muffin 6 count due to a labeling error. The affected product was mislabel…
    fda-agency-news
    fda-agency-news February 13, 2025

    FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

    AI/ML can help bring safe, effective, and high-quality treatments to patients faster. This post highlights the discussion papers, “Using Artificial …
    fda-agency-news
    fda-agency-news February 12, 2025

    Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies

    While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Food and Drug Administration will remain engaged with n…
    fda-agency-news
    fda-agency-news February 12, 2025

    What to Know About Breast Implants

    The U.S. Food and Drug Administration regulates breast implants as medical devices. Get the latest information to help you make an informed decision about whether…

    fda-agency-news
    fda-agency-news February 12, 2025
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    What to Know About Breast Implants

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