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  • 1.  Guidance for Pre-IND meeting request

    Posted 30-Nov-2023 12:55

    Dear Sir,

    We are planning to submit Pre-IND  meeting request for product ,which require input from two different division pain and psychiatry. Do we need to send separate pre-IND meeting request having different division address?

    or we can mention both address in one meeting request cover letter:

    example:

    Attn: Division of Anaestheology

    Attn: Division of Psychiatry

    Do we need to request separate in person meeting for each division input?

    Appreciates valuable inputs asap.

     

    Regards,

    Sapna



    ------------------------------
    sapna rathi
    Regulatory specialist
    AHME
    India
    ------------------------------


  • 2.  RE: Guidance for Pre-IND meeting request

    Posted 01-Dec-2023 09:18

    Dear Sapna,

    My experience. albeit limited, is that FDA will choose one primary review division and involve the reviewers of the second relevant division as appropriate. I would contact regulatory project management from both divisions and ask them to determine the primary review division.



    ------------------------------
    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    Scynexis, Inc.
    Burien WA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Guidance for Pre-IND meeting request

    Posted 01-Dec-2023 09:27

    Hi Sapna,

    My recommendation from having done this for a very long time is to determine which Division you want as your primary; Pain or Psychiatry. I would email the PM at the Division you want to lead the review & ask them if they would be able to lead the review & get input from the other Division. 

    There is always only one Division which will be your primary reviewer. Depending on your proposed indication statement, you'll know which one you would want to lead for your eventual IND submission. 



    ------------------------------
    Janaki Subramanyam RAC
    Vice President, Head of Regulatory Affairs
    Newton MA
    United States
    ------------------------------

    Original Message


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