Coronavirus (COVID-19) Update: Daily Roundup
SILVER SPRING, Md., July 1, 2020
SILVER SPRING, Md., July 1, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
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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
- Today, the U.S. Food and Drug Administration (FDA) further supported its effort to evaluate diagnostic tests for COVID-19 by distributing the first round of SARS-CoV-2 reference panel materials. The panel is an independent performance validation step — for diagnostic tests of SARS-CoV-2 infection — being used for clinical, not research, purposes. The reference panel can help characterize a test's level of detection and establish relative sensitivity among tests. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process or whose tests have been issued an EUA. The FDA will provide the reference panel to developers at the appropriate stage in the process.
- On June 30, FDA issued Emergency Use Authorizations to:
- On June 30, the FDA and the Federal Trade Commission jointly issued a warning letter to the Center for Wellness and Integrative Medicine for selling unapproved and unauthorized products to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The seller offers a "COVID Supplement Protection Pack" (also referred to as the "COVID Household Value Pack"), Thymosin-Alpha, and Methylene Blue Capsules for sale in the United States. There are currently no FDA-approved products to prevent or treat COVID-19. The warning letter advised the company to take immediate corrective actions to cease the sale of the unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- FAQs on Testing for SARS-CoV-2
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
- Coronavirus Disease 2019 (COVID-19)