Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., April 10, 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:

    --  The FDA recently issued an emergency use authorization (EUA) for a blood
        purification system to treat patients 18 years of age or older with
        confirmed COVID-19 admitted to the intensive care unit with confirmed or
        imminent respiratory failure. The FDA issued the EUA to Terumo BCT Inc.
        and Marker Therapeutics AG for their Spectra Optia Apheresis System and
        Depuro D2000 Adsorption Cartridge devices.

    --  The FDA recently issued an EUA to decontaminate compatible N95 or
        N95-equivalent respirators for reuse by health care workers in hospital
        settings. The FDA issued the EUA to STERIS Corporation for the STERIS
        V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using
        the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses
        vaporized hydrogen peroxide. This EUA will support decontamination of
        approximately 750,000 N95 respirators per day in the U.S.

    --  The FDA issued a guidance for immediate implementation for pharmacy
        compounders that experience shortages of the personal protective
        equipment (PPE) they typically use to compound human drugs that are
        intended or expected to be sterile. PPE shortages have the potential to
        significantly impact the quality, purity and availability of drugs that
        are compounded for patients, including those in critical need. The
        guidance discusses how pharmacies may be able to preserve PPE if
        supplies are limited. Further, as a temporary measure to address the
        public health emergency posed by COVID-19, the agency is providing
        limited regulatory flexibility for compounders that cannot obtain
        sufficient supplies of PPE for sterile compounding, provided they adopt
        risk mitigation strategies as described in the guidance. FDA adopted
        this policy to help assure patient access to needed medicines and to
        reduce the risks of compounding when standard PPE are not available.

    --  Yesterday, the FDA and Federal Trade Commission issued a warning letter
        to one company for selling fraudulent COVID-19 products, as part of the
        agency's effort to protect consumers. The seller warned, Earthley
        Wellness DBA Modern Alternative Mama LLC., offers unapproved and
        misbranded herbal tinctures and herbal remedy products for the
        prevention or treatment of COVID-19. There are currently no approved
        preventatives or treatments for COVID-19. Consumers should not purchase
        or take any product to prevent or treat COVID-19 unless it is prescribed
        by their health care provider and acquired from a legitimate source.

    --  FDA Voices: A Perspective on the FDA's COVID-19 Response by Mitch
        Zeller, director of the FDA's Center for Tobacco Products, was issued.
        It provides a perspective of the FDA's "all-hands-on-deck" approach to
        tackling this pandemic. The FDA is integral in the fight against the
        coronavirus, using science and innovative approaches to take a broad
        range of actions that advance our nation's response.

    --  The FDA issued a Letter to Stakeholders advising people not use
        ivermectin intended for animals as a treatment for COVID-19 in humans.
        People should never take animal drugs, as the FDA has only evaluated
        their safety and effectiveness in the particular animal species for
        which they are labeled. These animal drugs can cause serious harm in
        people. People should not take any form of ivermectin unless it has been
        prescribed to them by a licensed health care provider and is obtained
        through a legitimate source.
    --  Diagnostics update to date:
        --  During the COVID-19 pandemic, the FDA has worked with more than 300
            test developers who have said they will be submitting emergency use
            authorizations (EUA) requests to FDA for tests that detect the
            virus.
        --  To date, 33 emergency use authorizations have been issued for
            diagnostic tests.
        --  The FDA has been notified that more than 170 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