The FDA is continuing their weekly virtual town hall series presenting guidance on COVID-19 diagnostic testing.
On April 15, 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 SARS-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.
The FDA also plans to hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on the following dates:
- April 22, 2020 from 12:15 pm – 1:15 pm Eastern Time
- April 29, 2020 from 12:15 pm – 1:15 pm Eastern Time
Visit https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-immediately-effect-guidance-coronavirus-covid-19-diagnostic-tests-04152020 for call-in information and access to previously recorded sessions.
In response to the urgent need for information about the coronavirus crisis, BioCentury is providing a free information portal containing resources for the biopharma industry, and coverage on policy developments, scientific advances, and progress on countermeasures for COVID-19.
Join the webinar to hear from collaborators in the COVID-19 Therapeutics Accelerator.
- Lessons we can apply from past viral pandemics
- How smarter drug development accelerates therapeutics
- Activities and learnings to date at the COVID-19 Therapeutics Accelerator
- Tools, protocols, and resources for research studies in development
Dr. Steven Kern, Deputy Director of Quantitative Sciences, Bill & Melinda Gates Foundation
Dr. Craig Rayner, President of Integrated Drug Development, Certara
Date: April 8, 2020
Time: 1:00 pm ET
Duration: 1 hour
On March 25, 2020, the FDA held a virtual town hall to present their policy regarding running newly developed & validated SARS-CoV-2 tests prior to Emergency Use Authorization. The presentation is now available for download at https://www.fda.gov/media/136439/download.
Here is their summary slide: