U.S. markets closed

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

PR Newswire

SILVER SPRING, Md., June 12, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

Additional Resources:

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.

 

View original content to download multimedia:http://www.prnewswire.com/news-releases/coronavirus-covid-19-update-daily-roundup-301075359.html

SOURCE U.S. Food and Drug Administration

  • This week, the FDA issued an Emergency Use Authorization (EUA) for Cue Health Inc.'s Cue COVID-19 Test. This test is authorized for use at the Point of Care, that is, in patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Point-of-care testing means that results are delivered to patients in patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. This approach gives patients more immediate access to test results.
     
  • The FDA issued a warning letter to EUCYT Laboratories, LLC, for, among other things, marketing an unapproved exosome product for the treatment or prevention of COVID-19. There are currently no FDA-approved products to prevent or treat COVID-19.
     
  • Testing updates:
U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)
Cision