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

FDA cuts back on U.S. inspections due to COVID-19
In response to the COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) on March 18 announced that it was suspending all routine surveillance...
FDA updates FAQs for coronavirus diagnostic testing
The U.S. Food and Drug Administration (FDA) has updated its set of frequently asked questions (FAQs) that serve as guidelines for clinical labs that are...
FDA issues EUA for LabCorp coronavirus test
The U.S. Food and Drug Administration (FDA) on March 16 issued an emergency use authorization (EUA) to LabCorp for the company's coronavirus testing kit.
Gottlieb: More coronavirus kits coming, but so is crisis
More kits to diagnose the coronavirus are going to be available soon, but that doesn't mean the U.S. is out of the woods, according to Dr. Scott...
FDA moves to improve coronavirus testing access
The U.S. Food and Drug Administration (FDA) has taken two actions in an effort to improve access to coronavirus testing.

Copyright © 2020 LabPulse.com

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



Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.
Email
Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current