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UID:1498@azbio.org
DTSTART;TZID=America/Phoenix:20200708T091500
DTEND;TZID=America/Phoenix:20200708T101500
DTSTAMP:20200705T221234Z
URL:https://www.azbio.org/events/fda-virtual-town-hall-series-immediately-
 in-effect-guidance-on-coronavirus-covid-19-diagnostic-tests
SUMMARY:FDA Virtual Town Hall Series - Immediately in Effect Guidance on Co
 ronavirus (COVID-19) Diagnostic Tests - Webinar - 8 Jul 20 09:15
DESCRIPTION:Virtual Town Hall Series - Immediately in Effect Guidance on Co
 ronavirus (COVID-19) Diagnostic Tests\n\nMeeting Information\nDate:\nJuly 
 8\, 2020\nTime:\n9:15 -10:15 AM AZ MST (12:15 PM - 1:15 PM ET)\n\nSummary:
 \nOn July 8\, 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 l
 aboratories and commercial manufacturers that are developing or have devel
 oped diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to 
 help answer technical questions about the development and validation of te
 sts for SARS-CoV-2.\n\nThe FDA will also hold virtual Town Halls for clini
 cal laboratories and commercial manufacturers to help answer questions on:
 \n\nJuly 15\, 2020 from 12:15 pm – 1:15 pm Eastern Time\nJuly 22\, 2020 
 from 12:15 pm – 1:15 pm Eastern Time\nJuly 29\, 2020 from 12:15 pm – 1
 :15 pm Eastern Time\n\nOutlook users: Click link\, select Open\, then clic
 k Save &amp\; Close\n\nBackground:\nThe FDA plays a critical role in prote
 cting the United States from threats such as emerging infectious diseases\
 , including the Coronavirus Disease 2019 (COVID-19) pandemic. The FDA is c
 ommitted to providing timely guidance to support response efforts to this 
 pandemic.\n\nThe immediately in effect guidance "Policy for Coronavirus Di
 sease-2019 Tests During the Public Health Emergency (Revised)" includes po
 licies specific to this public health emergency. This guidance was issued 
 on February 29\, 2020 and subsequently updated on March 16\, 2020\, May 4\
 , 2020\, and May 11\, 2020.\n\nStakeholder Call Details:\nRegistration is 
 not necessary.\n\nDate: Multiple Dates\n\nTime: 12:15 p.m. – 1:15 p.m.\n
 To ensure you are connected\, please dial in 15 minutes prior to the start
  of the call.\n\nU.S. Callers Dial:\n\n888-455-1392\nConference Number: RW
 XW1462599\nPasscode: 7068896\nInternational Callers Dial:\n\n1-773-799-384
 7\nConference Number: RWXW1462599\nPasscode: 7068896\nTo view the slide pr
 esentation during the webinar:\nhttps://www.mymeetings.com/nc/join.php?i=R
 WXW1462599&amp\;p=7068896&amp\;t=
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