The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
- A new FDA Voices, tilted FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability, describes how FDA has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports. The agency engaged with the lab and commercial manufacturer communities even before any cases of COVID-19 were diagnosed in the United States, working with more than 500 developers since January. FDA has been working around the clock to issue more than 180 Emergency Use Authorizations (EUAs) tests, including molecular, serology, antigen, and tests with at-home-specimen-collection indications.
- Today, FDA delivered written testimony to the Senate Subcommittee on Manufacturing, Trade, and Consumer Protection. The statement, titled Protecting Americans from COVID-19 Scams, was by Catherine Hermsen, FDA’s Assistant Commissioner, Office of Criminal Investigations, Office of Regulatory Affairs.
- Testing updates:
- To date, the FDA has currently authorized 186 tests under EUAs; these include 153 molecular tests, 31 antibody tests, and 2 antigen tests.
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