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:20231115T174253Z DESCRIPTION:Date: Tuesday\, December 12\, 2023 \nTime: 1 – 2:00 PM ET\n \ nBackground:\nThe U.S. Food and Drug Administration (FDA) will host a webi nar for the medical device industry and other interested stakeholders to e xplain the scope and goals of the new voluntary pilot program for certain oncology drugs used with certain in vitro diagnostic tests\, and describe how to complete CDRH templates to provide analytical validation and perfor mance characteristic information for clinical trial assays used in the piv otal trial(s) for drug products under the pilot program\, when requested b y FDA.\n \nWebinar Connection Instructions\n* We encourage you to join at least 15 minutes prior to the start of the webinar.\n* You do not need to register to attend.\n* We recommend you join via the Zoom app using the Zo om link provided below. Listen through your computer speakers and speak th rough your computer microphone/headset to ask a question. \n \n* Webinar L ink: https://fda.zoomgov.com/j/1609808334?pwd=Q0MrcDFpZFg5S0lESmpnVjhHRGFo Zz09 \n* Passcode: pQCG3#\n \nIf you join by phone only without the Zoom l ink:\n* U.S. Callers Dial: 833-568-8864 (Toll Free)\no For higher quali ty\, dial a number based on your current location: \n * +1 669 254 5252 U S (San Jose) \n * +1 646 828 7666 US (New York) \n * +1 646 964 1167 U S (US Spanish Line) \n * +1 415 449 4000 US (US Spanish Line) \n * +1 551 285 1373 US (New Jersey) \n * +1 669 216 1590 US (San Jose) \n* Inte rnational Callers Dial: Please check the international numbers available < https://fda.zoomgov.com/u/adFgHqGG8t> \n \n* Webinar ID: 160 980 8334\n* P asscode: 677736\n \n DTEND;TZID="Eastern Standard Time":20231212T140000 DTSTAMP:20231115T174254Z DTSTART;TZID="Eastern Standard Time":20231212T130000 LAST-MODIFIED:20231115T174253Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E0080000000040CBE050C017DA01000000000000000 0100000004F0D030CC00BA14CBD09E79CB2D9C06A X-ALT-DESC;FMTTYPE=text/html:

Date: Tuesday\, December 12\, 2023

Time: 1 –\; 2:00 PM ET

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Background:

The U.S. Food and Dru g Administration (FDA) will host a webinar for the medical device industry and other interested stakeholders to explain the scope and goals of the n ew voluntary pilot program for certain oncology drugs used with certain in vitro diagnostic tests\, and describe how to complete CDRH templates to p rovide analytical validation and performance characteristic information fo r clinical trial assays used in the pivotal trial(s) for drug products und er the pilot program\, when requested by FDA.

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Webinar Connection Instructions

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If you join by phone only without the Zoom lin k:

o \; \; For higher qual ity\, dial a number based on your current location: \;

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  • International Callers Dial: Please check the international numb ers available

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