Jun 22, 2020   SOURCE: PR NewsWire

Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., June 22, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

    --  The FDA issued a guidance document, titled "Effects of the COVID-19
        Public Health Emergency on Formal Meetings and User Fee Applications for
        Medical Devices - Questions and Answers," with answers to frequently
        asked questions. These include answers concerning certain aspects of
        sponsor requests for formal meetings with the FDA, user-fee application
        goals and timelines, and other regulatory and policy issues related to
        device development for the duration of the COVID-19 public health
        emergency.
    --  As part of the FDA's continuing effort to protect consumers, the agency
        issued a warning letter to one firm for selling fraudulent COVID-19
        products. The seller, North Isle Wellness Center, offers Methylene Blue
        products for sale in the United States with misleading claims that the
        products can mitigate, prevent, treat, or cure COVID-19 in people. The
        letter requests that the seller take immediate action to cease the sale
        of such unapproved and unauthorized products. There are currently no
        FDA-approved products to prevent or treat COVID-19. Consumers concerned
        about COVID-19 should consult with their health care provider.
    --  Testing updates:
        --  To date, the FDA has authorized 145 tests under EUAs; these include
            122 molecular tests, 22 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: Lee.Herring@fda.hhs.gov, 240-402-6386
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