Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., May 26, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

    --  The FDA issued an Emergency Use Authorization (EUA) in response to
        concerns relating to insufficient supply and availability of gowns and
        other apparel, such as operating-room shoe covers, for use by health
        care personnel as personal protective equipment (PPE) for use in health
        care settings in accordance with Centers for Disease Control and
        Prevention recommendations to protect both health care personnel and
        patients from the transfer of SARS-CoV-2, the virus that causes
        COVID-19, in low or minimal risk level situations to prevent the spread
        of COVID-19.
    --  The FDA provided flexibility to farms regarding eligibility for the
        qualified exemption under the Produce Safety Rule during the COVID-19
        public health emergency. Farms that are currently eligible for the
        qualified exemption and associated modified requirements will still be
        considered eligible, even if they shift sales away from qualified
        end-users, so long as they continue to meet the requirement that their
        average food sales during the previous three years total less than
        $500,000 (adjusted for inflation).
    --  The FDA approved an abbreviated new drug application (ANDA) for
        succinylcholine chloride injection USP 200 mg/10 mL, which is indicated
        in addition to general anesthesia, to facilitate tracheal intubation and
        to provide skeletal muscle relaxation during surgery or mechanical
        ventilation. Side effects of succinylcholine chloride injection include
        anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA
        recognizes the increased demand for certain products during the COVID-19
        public health emergency, and we remain deeply committed to facilitating
        access to medical products to help address critical needs of the
        American public.
    --  Testing updates:
        --  During the COVID-19 pandemic, the FDA has worked with more than 400
            test developers who have already submitted or said they will be
            submitting EUA requests to the FDA for tests that detect the virus
            or antibodies to the virus.
        --  To date, the FDA has authorized 113 tests under EUAs, which include
            100 molecular tests, 12 antibody tests, and 1 antigen test.

Additional Resources:

    --  FAQs on Testing for SARS-CoV-2
    --  Policy for Coronavirus Disease-2019 Tests During the Public Health
        Emergency (Revised)
    --  Coronavirus Disease 2019 (COVID-19)

Media Contact:, 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.

View original content to download multimedia:

SOURCE U.S. Food and Drug Administration