BEGIN:VCALENDAR PRODID:-//Microsoft Corporation//Outlook 16.0 MIMEDIR//EN VERSION:2.0 METHOD:PUBLISH X-MS-OLK-FORCEINSPECTOROPEN:TRUE BEGIN:VTIMEZONE TZID:Eastern Standard Time BEGIN:STANDARD DTSTART:16011104T020000 RRULE:FREQ=YEARLY;BYDAY=1SU;BYMONTH=11 TZOFFSETFROM:-0400 TZOFFSETTO:-0500 END:STANDARD BEGIN:DAYLIGHT DTSTART:16010311T020000 RRULE:FREQ=YEARLY;BYDAY=2SU;BYMONTH=3 TZOFFSETFROM:-0500 TZOFFSETTO:-0400 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT CLASS:PUBLIC CREATED:20200527T192215Z DESCRIPTION:On June 3\, 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 valid ation of tests for SARS-CoV-2.\n \nThe FDA will continue to hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on the following dates in June:\n* June 10\, 2020 from 12 :15 pm – 1:15 pm Eastern Time\n* June 17\, 2020 from 12:15 pm – 1:15 p m Eastern Time\n* June 24\, 2020 from 12:15 pm – 1:15 pm Eastern Time\n \n \nBackground:\nThe FDA plays a critical role in protecting the United S tates from threats such as emerging infectious diseases\, including the Co ronavirus Disease 2019 (COVID-19) pandemic. The FDA is committed to provid ing timely guidance to support response efforts to this pandemic. \nThe im mediately in effect guidance “Policy for Coronavirus Disease-2019 T ests During the Public Health Emergency (Revised) includes policies specif ic to this public health emergency. This guidance was issued on February 2 9\, 2020 and subsequently updated on March 16\, 2020\, May 4\, 2020\, and May 11\, 2020.\n \nStakeholder Call Details:\nRegistration is not necessar y.\n \nDate: Multiple Dates (please see above)\nTime: 12:15 p.m. – 1:15 p.m.\n\n\nTo ensure you are connected\, please dial in 15 minutes prior to the start of the call.\nU.S. Callers Dial:\n* 888-455-1392\n* Conference Number: RWXW1364028\n* Passcode: 7068896\nInternational Callers Dial:\n* 1-773-799-3847\n* Conference Number: RWXW1364028\n* Passcode: 7068896\nTo view the slide presentation during the webinar:\nhttps://www.mymeetings.co m/nc/join.php?i=RWXW1364028&p=7068896&t=c \n \nFollowing the webinar\, a t ranscript\, recoding and slides will be available at:\nhttp://www.fda.gov/ CDRHWebinar\n \n DTEND;TZID="Eastern Standard Time":20200603T131500 DTSTAMP:20200527T192216Z DTSTART;TZID="Eastern Standard Time":20200603T121500 LAST-MODIFIED:20200527T192215Z LOCATION:FDA- WebEx PRIORITY:5 RRULE:FREQ=WEEKLY;COUNT=4;BYDAY=WE SEQUENCE:0 SUMMARY;LANGUAGE=en-us:Virtual Town Hall Series - Immediately in Effect Gui dance on Coronavirus (COVID-19) Diagnostic Tests TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000E0A2A0FA3934D601000000000000000 01000000015BBB51CF40A9544B8F4A4FD33A3A920 X-ALT-DESC;FMTTYPE=text/html:

On June 3\, 2020\, from 12:15 pm –\; 1:15 pm Eastern Time\, the U.S. Food an d Drug Administration (FDA) will host a virtual Town Hall for clinical lab oratories and commercial manufacturers that are developing or have develop ed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to he lp answer technical questions about the development and validation of test s for SARS-CoV-2.

 \;

< p class=MsoNormal>The FDA will continue to hold \; virtual Town Halls for clinical laboratories and commer cial manufacturers to help answer questions on the following dates in June :

  • June 10\, 2020 from 12:15 pm –\; 1:15 pm Eastern Time
  • June 17\, 2020 fr om 12:15 pm –\; 1:15 pm Eastern Time
  • June 24\, 2020 from 12:15 pm –\; 1:15 pm Eastern Time

 \;

 \;

Background:

The F DA plays a critical role in protecting the United States from threats such as emerging infectious diseases\, including the Coronavirus Disease 2019 (COVID-19) pandemic. The FDA is committed to providing timely guidance to support response efforts to this pandemic.

The immediately in effect guidance “\;Policy for Coronavirus Disease-2019 Tests During the Publi c Health Emergency (Revised) includes policies specific to this public health emergency. This guidance was issued on February 29\, 2020 and subs equently updated on March 16\, 2020\, May 4\, 2020\, and May 11\, 2020.

 \;

Stakeholder Call Details:

Reg istration is not necessary.

  \;

Date: \;Multiple Dates (plea se see above)

Time: \;12:15 p. m. –\; \;1:15 p.m.

To ensure you are connected\, please dial in 15 minutes prior to the start of the call.

< p class=MsoNormal>U.S. Callers Dial:

  • 888-455-1392
  • Conference Number: RWXW1364 028
  • Passcode: \; 7068896

International Callers Dial:

  • 1-773-799-3847
  • Conference Number: RWXW136 4028
  • Passcode: 7068896

To view the slide presentation during the webinar:
https ://www.mymeetings.com/nc/join.php?i=RWXW1364028&\;p=7068896&\;t=c

 \;

Following the webinar\, a transcript\, recoding and slides will be avai lable at:
http://www.fda.gov/C DRHWebinar

 \;

X-MICROSOFT-CDO-BUSYSTATUS:BUSY X-MICROSOFT-CDO-IMPORTANCE:1 X-MICROSOFT-DISALLOW-COUNTER:FALSE X-MS-OLK-AUTOFILLLOCATION:FALSE X-MS-OLK-CONFTYPE:0 BEGIN:VALARM TRIGGER:-PT15M ACTION:DISPLAY DESCRIPTION:Reminder END:VALARM END:VEVENT END:VCALENDAR