FDA to Hold Virtual Town Hall on Diagnostic Tests for COVID-19

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The U.S. Food and Drug Administration (FDA) will hold a virtual town hall tomorrow (March 25) at 3 p.m. Eastern Time designed for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2 (COVID-19). The purpose of the meeting, which is part of a series, is to help answer technical questions about the development and validation of tests for SARS-CoV-2 and the guidance issued March 16, Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency.

More information on the Virtual Town Hall Series is on the FDA website.

The FDA also plans to hold virtual town halls for clinical laboratories and commercial manufacturers to help answer questions on the following dates:

  • April 1, 2020 from 3 p.m. – 4 p.m. Eastern Time
  • April 8, 2020 from 3 p.m. – 4 p.m. Eastern Time
  • April 15, 2020 from 3 p.m. – 4 p.m. Eastern Time
  • April 22, 2020 from 3 p.m. – 4 p.m. Eastern Time
  • April 29, 2020 from 3 p.m. – 4 p.m. Eastern Time

Industry continues to appreciate FDA’s actions of late in battling the coronavirus, including issuing the March guidance.

“The guidance came out right as things were escalating, so I applaud them for the sense of urgency,” says Ashley Parish, vice president for strategic alliances at Teckro.

Edited by Michael Causey