FDA COVID-19 Update

The following are some of the U.S. FDA’s actions taken, as of April 17, in its ongoing response effort to the COVID-19 pandemic:

The National Institutes of Health (NIH) and the Foundation for the NIH announced a public-private partnership with the FDA and others to speed the development of COVID-19 vaccine and treatment options. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership also includes the U.S. Centers for Disease Control and Prevention, the European Medicines Agency, the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, as well as more than a dozen biopharmaceutical companies. The ACTIV partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.

FDA announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose. As part of this effort, U.S. Cotton, the largest manufacturer of cotton swabs and a subsidiary of Parkdale-Mills, developed a polyester-based Q-tip-type swab that is fully synthetic for compatibility with COVID-19 testing. Harnessing its large-scale U.S.-based manufacturing capabilities, U.S. Cotton plans to produce these new polyester swabs in large quantities to help meet the needs for coronavirus diagnostic testing.

Diagnostics update to date:

• During the COVID-19 pandemic, the FDA has worked with more than 320 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
• To date, the FDA has issued 39 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 16 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
• The FDA has been notified that more than 190 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
• The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
   

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