Jul 20, 2020   SOURCE: PR NewsWire

Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., July 20, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

    --  The FDA reissued an Emergency Use Authorization (EUA) to Quest
        Diagnostics for its Quest SARS-CoV-2 rRT-PCR test, which is now
        authorized for use with pooled samples containing up to four individual
        upper-respiratory swab specimens collected under observation. The Quest
        test is the first COVID-19 diagnostic test to be authorized for use with
        pooled samples.
    --  In a new FDA Voices, titled FDA Protects Patients and Consumers from
        Fraud During COVID-19, agency leaders explain that the FDA's consumer
        protection work is a cornerstone of the agency's mission and a critical
        component of its pandemic response efforts.
    --  In another new FDA Voices, titled FDA's Continued Commitment to the
        Safety and Security of Our Laboratories, agency leaders explain that
        laboratory safety is of the highest priority in all of the agency's
        scientific research and analytical facilities.
    --  Today, FDA announced that it is extending the enforcement discretion
        policy for certain human cell, tissue, and cellular and tissue-based
        products (HCT/Ps). As a result of the challenges presented by the
        COVID-19 public health emergency, the agency is extending the
        enforcement discretion policy for an additional six months (through May
        2021).
    --  Today, the FDA immediately implemented and issued a guidance intended to
        help expand the availability of transport media used to transport
        certain clinical specimens for testing during the COVID-19 public health
        emergency. The FDA also posted answers to frequently asked questions
        relating to the development and use of transport media during the
        COVID-19 public health emergency.


    --  Testing updates:
        --  To date, the FDA has currently authorized 186 tests under EUAs;
            these include 153 molecular tests, 31 antibody tests, and 2 antigen
            tests.

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: Lee.Herring@fda.hhs.gov
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