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  • 1.  FDA Meeting Requests

    This message was posted by a user wishing to remain anonymous
    Posted 20-Mar-2020 11:10
    This message was posted by a user wishing to remain anonymous

    Hi all,

    Considering the COVID-19 pandemic where everyone is encouraged/mandated to telework from home, does this impact potential F2F formal meetings between FDA and sponsors. Also, will there be any relaxation on sending meeting desk/paper copies to CDER for time being. Your response is highly appreciated.

    Thank you.


  • 2.  RE: FDA Meeting Requests

    Posted 21-Mar-2020 10:31
    This could impact a F2F meeting with FDA, this depends largely on what the FDA district policy is regarding the timing for F2F meetings given many cites have a stay-in-place order; and city/state government restrictions concerning same.   Contact the district office directly.

    You will have to contact CDER directly regarding any documentation they have requested, and how they wish to receive it.

    ------------------------------
    Mark Balboni
    Bend OR
    United States
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    Original Message


  • 3.  RE: FDA Meeting Requests

    Posted 22-Mar-2020 08:08
    Regarding F2F meetings, my understanding with COVID-19 now here is that at least through April, FDA is postponing F2F already scheduled and not scheduling new meetings.

    Anyone else confirm this? I thought I saw an announcement from FDA on this, that only teleconference meetings will be scheduled.

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 4.  RE: FDA Meeting Requests

    Posted 22-Mar-2020 08:20
    I was to participate in a F2F meeting with FDA the week of March 9 which was changed to a teleconference. My understanding is that all F2F meetings have been changed to teleconferences until further notice. Regarding Briefing Documents, I agree, need to correspond with CDER.

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    Beverly Lewis RAC
    President
    Nags Head NC
    United States
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    Original Message


  • 5.  RE: FDA Meeting Requests

    Posted 22-Mar-2020 14:20
    Yes, I understand all F2F meetings are being postponed, re-scheduled, or moved to a teleconference as able.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 6.  RE: FDA Meeting Requests

    Posted 23-Mar-2020 08:30
    Hi all,

    Face to face is being postponed.  I think also to end of April.  However, as with most FDA meetings, the briefing document will contain a list of questions that the FDA should respond to prior to the scheduled meeting.  The agency originally gave us three options before the Covid-19 pandemic. After receiving its written response; continue with the face-to-face, set up a teleconference or accept the responses as written.  In my judgment, depending upon FDA staff availability the teleconference and acceptance of the written responses may still occur.  We have found this to be the case with our requests.

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    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------

    Original Message


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