Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., April 20, 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 issued information on the use of serological (antibody) tests to
        help identify people who may have been exposed to the SARS-CoV-2 virus
        or have recovered from the COVID-19 infection. This information
        --  Important Information on the Use of Serological (Antibody) Tests for
            COVID-19 - Letter to Health Care Providers;
        --  FDA Fact Sheet - Serological Testing for Antibodies to SARS-CoV-2
            Infection; and

        --  New Serology/Antibody Test FAQs in the FAQs on Diagnostic Testing
            for SARS-CoV-2.

    --  The FDA issued a face mask emergency use authorization (EUA) in response
        to concerns relating to insufficient supply and availability of face
        masks for use by members of the general public, including health care
        personnel in healthcare settings as personal protective equipment (PPE),
        to cover their noses and mouths, in accordance with Centers for Disease
        Control and Prevention (CDC) recommendations, to prevent the spread of
        the SARS-CoV-2 virus during the pandemic. Manufacturers of face masks
        that are used as described in the EUA and meet the requirements in the
        EUA, do not need to take any action, other than complying with the
        Conditions of Authorization in the EUA, to be authorized under this EUA.

    --  Today, the FDA issued a guidance explaining a temporary policy regarding
        state-licensed pharmacies and federal facilities, that are not
        outsourcing facilities, compounding certain human drugs for hospitalized
        patients during the COVID-19 public health emergency. This guidance
        explains the agency's policy to help address reported issues with
        accessing certain FDA-approved drugs used for hospitalized patients with
        COVID-19. As a temporary measure, with regard to certain drugs, under
        the circumstances outlined in the guidance, FDA does not intend to take
        action against state-licensed pharmacies and federal facilities for
        compounding a drug that is essentially a copy of a commercially
        available drug, or for providing a drug to a hospital without obtaining
        a patient-specific prescription. When a hospital is unable to access
        FDA-approved drug products and is considering the use of compounded
        drugs for hospitalized patients, outsourcing facilities may be able to
        offer a supply of compounded drugs that are subject to more robust
        quality standards than are drugs produced by State-licensed pharmacies
        or Federal facilities that are not required to comply with CGMP

    --  A new FDA Voices was issued, The Path Forward: Coronavirus Treatment
        Acceleration Program, describing a new program that aims to move new
        treatments to patients as soon as possible, while at the same time
        finding out whether they are helpful or harmful. So far, 72 clinical
        trials of potential therapies for COVID-19 are underway with FDA
        oversight. Both the pharmaceutical industry and academic researchers
        have submitted many innovative and well-designed studies for prevention
        and treatment of COVID-19. The FDA has streamlined its review and advice
        process to get studies started as quickly as possible.
    --  Diagnostics update to date:
        --  During the COVID-19 pandemic, the FDA has worked with more than 340
            test developers who have said they will be submitting emergency use
            authorization (EUA) requests to FDA for tests that detect the virus.
        --  To date, the FDA has issued 41 individual emergency use
            authorizations for test kit manufacturers and laboratories. In
            addition, 16 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 210 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

Additional Resources:

    --  Coronavirus Disease 2019 (COVID-19)

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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