Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., March 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:

    --  The FDA is facilitating access to convalescent plasma, antibody-rich
        blood products that are taken from blood donated by people who have
        recovered from the COVID-19 virus, that could shorten the length, or
        lessen the severity, of the illness. The agency will be using multiple
        pathways to support these efforts and has posted information for
        investigators wishing to study convalescent plasma for use in patients
        with serious or immediately life-threatening COVID-19 infections through
        the process of single patient emergency Investigational New Drug
        Applications for individual patients. The FDA also is actively engaging
        with researchers to discuss the possibility of collaboration on the
        development of a master protocol for the use of convalescent plasma,
        with the goal of reducing duplicative efforts.
    --  In response to this evolving public health emergency and continued
        filtering facepiece respirator (FFR or respirator) shortages, FDA has
        concluded based on the totality of scientific evidence available that
        certain imported disposable FFRs that are not NIOSH-approved are
        appropriate to protect the public health or safety. Under this EUA,
        authorized respirators listed in the letter are authorized for use in
        healthcare settings by healthcare personnel when used in accordance with
        CDC recommendations to prevent wearer exposure to pathogenic biological
        airborne particulates during FFR shortages resulting from the
        Coronavirus Disease 2019 (COVID-19) outbreak.
        --  Letter of Authorization
        --  Non-NIOSH Approved Respirator EUA FAQ
    --  The FDA issued a Consumer Update advising consumers to be beware of
        fraudulent coronavirus tests, vaccines and treatments. The FDA is
        particularly concerned that deceptive and misleading products might
        cause Americans to delay or stop appropriate medical treatment, leading
        to serious and life-threatening harm. It's likely that the products do
        not do what they claim, and the ingredients in them could cause adverse
        effects and could interact with, and potentially interfere with,
        essential medications. There are no FDA-approved products to prevent
        COVID-19. For example, the FDA is aware of people trying to prevent
        COVID-19 by taking a product called chloroquine phosphate, which is sold
        to treat parasites in aquarium fish. Products for veterinary use or for
        "research use only" may have adverse effects, including serious illness
        and death, when taken by people. The agency warns not to take any form
        of chloroquine unless it has been prescribed by a health care provider
        and obtained from legitimate sources.
    --  Diagnostics update: In certain emergencies, the FDA can often quickly
        issue an emergency use authorization for diagnostic tests based on FDA's
        rolling review of data and where the request meets certain criteria. In
        the COVID-19 pandemic, the FDA has worked with more than 190 test
        developers who have said they will be submitting applications to make
        tests that detect the virus. To date, 16 emergency use authorizations
        have been issued for nation-wide use, including one today. Under our
        laboratory developed test policy during COVID-19, the FDA has been
        notified by more than 65 laboratories.
    --  The FDA issued a Letter to Industry that includes steps the Center for
        Devices and Radiological Health (CDRH) has taken to prioritize work that
        advances the nation's response during the Coronavirus Disease 2019
        (COVID-19) public health emergency. These steps seek to address the
        impact of COVID-19 public health emergency on day-to-day operations in
        CDRH and in the medical device industry, while ensuring that government
        and private sector efforts to respond to this national emergency receive
        the highest priority.
    --  The FDA provided flexibility to veterinarians who want to utilize
        telemedicine to prescribe certain drugs for animals by temporarily
        suspending enforcement of portions of the federal
        veterinarian-client-patient relationship requirements. This helps
        veterinarians continue to care for animals while minimizing
        person-to-person contact between veterinary staff and the animal owner
        or caretaker, allowing for the social distancing that is so important in
        limiting the further spread of coronavirus.
    --  The FDA explained how the agency is working with experts around the
        world to find ways to prevent and treat COVID-19, including
        collaborating with international organizations to facilitate the
        development of a vaccine: FDA Voices: FDA and EMA Collaborate to
        Facilitate SARS-CoV-2 Vaccine Development.
    --  The FDA took action to increase U.S. supplies to support the U.S.
        response to COVID-19 by providing instructions to manufacturers
        importing personal protective equipment and other devices. The agency is
        engaging with importers and others involved in the import trade
        community during this pandemic to facilitate the entry of needed
        products, including PPE, into the U.S. These instructions to importers
        clarify the types of PPE that can be imported without engaging with FDA.
        They also include information about the type of information importers
        can submit to facilitate their entries.
    --  The FDA provided an update, FDA Offers Assurance About Food Safety and
        Supply for People and Animals During COVID-19, to explain that the U.S.
        food supply remains safe for both people and animals. There is no
        evidence of human or animal food or food packaging being associated with
        transmission of the coronavirus that causes COVID-19. Additionally,
        overall, retail supply chains remain strong, and the FDA is working with
        food manufacturers and grocery stores to closely monitor the human food
        supply chain for any shortages. The same is true for animal food. The
        FDA is monitoring the availability of foods for livestock and pets.
        There are no shortages, and no current disruptions in the pet and
        livestock food supply chain.

Additional Resources:

    --  Coronavirus Disease 2019 (COVID-19)

Media Contact: Stephanie Caccomo, 301-348-1956
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