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Food and Drug Administration and Compliance Issues
Monday, June 1, 2020
Coronavirus (COVID-19) Update: Daily Roundup June 1, 2020
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 Consumer Update, Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19. Scientists are working hard to develop a number of potential drugs for the prevention or treatment of coronavirus, but none are currently approved by the FDA for these purposes. The language used to describe potential therapies can be confusing, and there’s public interest around the FDA’s work to ensure access to potentially life-saving treatments. This Consumer Update explains some of the regulatory terminology.
During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 117 tests under EUAs, which include 101 molecular tests, 15 antibody tests, and 1 antigen test.