Authorization

Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., July 17, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

As part of the FDA's effort to protect consumers, the agency issued warning letters to operators of two websites (www.hydroxychloroquine-online.com and www.pharmaboosters.com) that market unapproved COVID-19 products. There are currently no FDA-approved drugs to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. Consumers can visit BeSafeRx to learn about how to safely buy medicine online.




On July 15, 2020, the agency approved an abbreviated new drug application, or generic, for heparin sodium. This drug is an anti-coagulant to prevent blood clotting. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency and remains deeply committed to facilitating access to medical products to help address critical needs of the American public.




FDA issued Emergency Use Authorizations to:



Boston Heart Diagnostics for its molecular Boston Heart COVID-19 RT-PCR Test



Luminex Corporation for its serology xMAP SARS-CoV-2 Multi-Antigen IgG Assay




Testing updates:



To date, the FDA has currently authorized 184 tests under EUAs; these include 152 molecular tests, 30 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:A Lee.Herring@fda.hhs.govA 
Consumer Inquiries: 888-INFO-FDAThe 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.
Coronavirus (COVID-19) Update: Daily Roundup
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