FDA Virtual Town Hall Series

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.


BIOCENTURY: Updates on Therapeutic Advances

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.

 

https://www.biocentury.com/coronavirus


Directory of COVID Diagnostic Pipeline

Active overview of all SARS-CoV-2 tests commercially available or in development for the diagnosis of COVID-19. Collated by test suppliers or obtained from publicly available sources.

 

https://www.finddx.org/covid-19/pipeline/


COVID Webinars: Accelerating Therapeutics for COVID-19

Join the webinar to hear from collaborators in the COVID-19 Therapeutics Accelerator.

Topics Including:

  • 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
Speaker(s): 
Dr. Dan Hartman, Director of Integrated Development, Bill & Melinda Gates Foundation
Dr. Steven Kern, Deputy Director of Quantitative Sciences, Bill & Melinda Gates Foundation
Dr. Craig Rayner, President of Integrated Drug Development, Certara
Dr. Fran Brown, SVP of Integrated Drug Development, Certara
Date: April 8, 2020
Time: 1:00 pm ET
Duration: 1 hour

https://lp.certara.com/WBN-2020-04-08AcceleratingTherapeuticsforCOVID19_LP-Registration.html


FDA Policy on COVID-19 Testing During Public Health Emergency

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:

 



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