FDA hosts town hall on diagnostic testing for novel coronavirus

By LabPulse.com staff writers

March 20, 2020 -- The U.S. Food and Drug Administration (FDA) will host a virtual town hall on March 25 for clinical laboratories and commercial manufacturers to discuss issues related to diagnostic testing for SAR-CoV-2, the virus that causes COVID-19.

The town hall, which is set to begin at 3 p.m. EST, will provide a forum for addressing technical questions about the development and validation of tests for SARS-CoV-2, as well as guidance that was recently issued. The guidance permits labs to develop their own tests for the novel coronavirus, without getting an emergency use authorization (EUA) from the FDA. The agency recently issued EUAs to a range of companies, including LabCorp, Quidel, and Hologic.

Next month, the FDA plans to hold virtual town halls for clinical laboratories and commercial manufacturers on the following days at 3 p.m. EST:

  • April 1
  • April 8
  • April 15
  • April 22
  • April 29

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Copyright © 2020 LabPulse.com

Last Updated np 3/20/2020 3:14:15 PM

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