martes, 31 de marzo de 2020

Reminder: April 1- Virtual Town Hall for the Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests



Reminder:  April 1- Virtual Town Hall for the Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests


On Wednesday, April 1, 2020, from 12:15 pm - 1:15 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. To ensure you are connected, please dial in 15 minutes prior to the start of this virtual Town Hall.

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 FDA’s updated policy on COVID-19 Diagnostics issued on March 16, 2020, Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.

SAVE THE DATE:

The FDA also plans to hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on the following dates:
  • April 8, 2020 from 1:15 pm – 2:15 pm Eastern Time
  • April 15, 2020 from 1:15 pm – 2:15 pm Eastern Time
  • April 22, 2020 from 1:15 pm – 2:15 pm Eastern Time
  • April 29, 2020 from 1:15 pm – 2:15 pm Eastern Time

Questions?
For general questions, including about this Town Hall, contact Division of Industry and Consumer Education.

For specific questions about COVID-19 diagnostic development, contact CDRH-EUA-Templates@fda.hhs.gov.

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