Summary:
On Wednesday, March 25, 2020, from 3 pm – 4 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2 and the recently issued guidance.
The FDA also plans to hold virtual town halls for clinical laboratories and commercial manufacturers to help answer questions on the following dates:
March 25, 2020 from 3:00 pm – 4:00 pm Eastern Time
April 1, 2020 from 3:00 pm – 4:00 pm Eastern Time
April 8, 2020 from 3:00 pm – 4:00 pm Eastern Time
April 15, 2020 from 3:00 pm – 4:00 pm Eastern Time
April 22, 2020 from 3:00 pm – 4:00 pm Eastern Time
April 29, 2020 from 3:00 pm – 4:00 pm Eastern TimeBackground:
On March 16, 2020, the FDA issued updated policy on COVID-19 Diagnostics: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
U.S. Food and Drug Administration