Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., April 24, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

    --  Today, he FDA issued an immediately in effect guidance, Enforcement
        Policy for Remote Digital Pathology Devices During the Coronavirus
        Disease 2019 (COVID-19) Public Health Emergency, to help expand the
        availability of devices for remote reviewing and reporting of scanned
        digital images of pathology slides during this public health emergency.
        Increased availability of these devices may help to facilitate
        continuity of patient care by preventing disruptions to critical
        pathology services rendered by clinical laboratories, hospitals, and
        other healthcare facilities, and reduce healthcare personnel contact and
        risk of exposure to SARS-CoV-2.

    --  Today, the FDA issued a Drug Safety Communication regarding known side
        effects of hydroxychloroquine and chloroquine, including serious and
        potentially life-threatening heart rhythm problems, that have been
        reported with their use for the treatment or prevention of COVID-19, for
        which they are not approved by the FDA. These risks, which are in the
        drug labels for their approved uses, may be mitigated when health care
        professionals closely screen and supervise these patients such as in a
        hospital setting or a clinical trial, as indicated in the Emergency Use
        Authorization (EUA) for these drugs to treat COVID-19.

    --  The FDA and Federal Trade Commission issued a warning letter to a seller
        of fraudulent COVID-19 products, as part of the agency's effort to
        protect consumers. The seller warned, Prefense LLC, offers unapproved
        and misbranded hand sanitizer products for sale in the U.S. with
        misleading claims that the products are safe and/or effective for the
        prevention and treatment of COVID-19. There are currently no
        FDA-approved products to prevent or treat COVID-19. Consumers concerned
        about COVID-19 should consult with their health care provider.
    --  Diagnostics update to date:
        --  During the COVID-19 pandemic, the FDA has worked with more than 380
            test developers who have said they will be submitting emergency use
            authorizations (EUA) requests to FDA for tests that detect the
            virus.
        --  To date, the FDA has issued 44 individual emergency use
            authorizations for test kit manufacturers and laboratories. In
            addition, 19 authorized tests have been added to the EUA letter of
            authorization for high complexity molecular-based laboratory
            developed tests (LDTs).
        --  The FDA has been notified that more than 225 laboratories have begun
            testing under the policies set forth in our COVID-19 Policy for
            Diagnostic Tests for Coronavirus Disease-2019 during the Public
            Health Emergency Guidance.
        --  The FDA also continues to keep its COVID-19 Diagnostics FAQ up to
            date.

Additional Resources:

    --  Coronavirus Disease 2019 (COVID-19)

Media Contact: Molly.Block@fda.hhs.gov, 240-701-7422
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, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration