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Summary:

The U.S. Food and Drug Administration (FDA) will continue hosting a virtual Town Hall series for SARS-CoV-2 (COVID-19) test developers and will now also include information and answer questions about monkeypox test development. For each Town Hall, the FDA will indicate whether the session will address COVID-19, monkeypox, or both.

Registration is not necessary.

There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing [email protected].

• Please submit questions by Monday 12 p.m. ET before the Wednesday virtual Town Hall.
• In the subject line of the email, type type “Questions for the Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies” and clearly indicate whether your question is about COVID-19 or monkeypox.

Save the Date:

The FDA will hold a virtual Town Hall for test developers from 12:05 p.m.-1 p.m. ET on:

• October 5: Town Hall #94 (Monkeypox)
• October 12: Town Hall #95 (Monkeypox)

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Background:

The FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including Coronavirus Disease 2019 (COVID-19) and monkeypox. The FDA is committed to providing timely guidance to support response efforts to these public health emergencies.

The FDA has issued guidance documents specific to these public health emergencies:

• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
• Policy for Monkeypox Tests to Address the Public Health Emergency

The recording and transcript from the previous town halls are available for viewing.

Virtual Town Hall Details:

Registration is not necessary.

Time: 12:05 p.m. - 1 p.m. ET
To ensure you are connected, please join 15 minutes before the start of the virtual Town Hall.

Please click the link below to join the webinar:

• https://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09
• Passcode: ^8@HvK

Please note: Participants who join the virtual Town Hall using the Zoom webinar link above should use computer audio (listen through computer speakers and speak through computer microphone/headset to ask a question).

The dial-in information provided below is for participants who will be joining the virtual Town Hall by phone only.

U.S. Callers Dial: 833-568-8864 (Toll Free)
International Callers Dial: Please check the international numbers available 
Webinar ID: 161 208 3563
Passcode: 728477

Following the webinar, a transcript, recording, and slides will be posted below.

Previous Town Halls for Test Development and Validation During Public Health Emergencies