Authorization

Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., July 30, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

On July 29, FDA updated its "Food Safety and the Coronavirus Disease" webpage of Questions and Answers (Q&A). The Center for Food Safety and Nutrition added a new Q&A item, titled "What do U.S. exporters of FDA-regulated food products need to consider related to COVID-19?"



On July 29, the FDA posted frequently asked questions for patients and consumers about antibody (serology) testing during the COVID-19 public health emergency. A COVID-19 antibody test, also known as a serology test, is a blood test that can detect if a person has antibodies to SARS-CoV-2, the virus that causes COVID-19. COVID-19 antibody tests can help identify people who may have been infected with the SARS-CoV-2 virus or have recovered from the COVID-19 infection.



Today, the FDA updated its frequently asked questions on the Emergency Use Authorization for Remdesivir for Certain Hospitalized COVID-19 Patients. The update includes a question regarding changes to Gilead's Fact Sheets for Health Care Providers and Patient and Parent/Caregivers. Gilead updated the fact sheets to incorporate the sponsor's use of the proprietary name Veklury.



Testing updates:



To date, the FDA has currently authorized 193 tests under EUAs; these include 158 molecular tests, 33 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.gov
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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