Nov 26, 2024   SOURCE: PR NewsWire

FDA Roundup: November 26, 2024

SILVER SPRING, Md., Nov. 26, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  On Monday, the FDA issued this guidance: Transitional Enforcement Policy
        for Ethylene Oxide Sterilization Facility Changes for Class III Devices
        which provides a transitional enforcement discretion policy for
        manufacturers of certain Class III devices to respond to anticipated
        changes in ethylene oxide (EtO) sterilization activities. The guidance
        helps to prevent or mitigate the potential risk of medical device supply
        chain disruptions or shortages during the time period in which
        sterilization facilities are transitioning to comply with new
        Environmental Protection Agency requirements. This guidance is being
        published as part of the FDA's efforts to mitigate potential impacts on
        the supply of sterile devices due to potential, actual, or temporary
        stops or reductions in operations at sterilization facilities that use
        EtO as a medical device sterilant.


    --  On Friday, the FDA approved Attruby (acoramidis) to treat adults with
        cardiomyopathy (disorder that affects heart muscle) of wild-type or
        variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) to
        reduce death and hospitalization related to heart problems. ATTR-CM is a
        rare and serious disease that affects the heart muscle. Recommended
        dosing for Attruby is available in the prescribing information.
    --  On Friday the FDA updated the advisory for the outbreak of E. coli
        linked to whole and baby organic carrots from Grimmway Farms. On
        November 21, 2024, the recall was expanded to include additional bag
        sizes for organic whole carrots under the following labels: to include
        additional bag sizes for organic whole carrots under the following
        labels:
-- Bunny Luv: 50-lb -- Cal-Organic: 15-lb and 50-lb -- Good & Gather: 1-lb

These products are likely no longer available for sale in stores but could be in people's homes. A full list of recalled products is on the firm's expanded recall announcement.

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