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  • 1.  INTERACT Meetings with Sponsors for Drugs and Biological Products

    Posted 11-Nov-2020 13:49
    Hello Everyone,

    We are working with a client to submit an INTERACT meeting request / package.  This was known as a pre-pre-IND meeting in the past and was in paper format.

    • Does anyone know if the INTERACT meeting request can be submitted via NextGen in PDF or is it now required to be submitted in eCTD?

    The FDA website has the SOPP for INTERACT meetings (which doesn't address package format for submission), but I can't find any guidance on submission format.

    Thanks in advance for any information you can provide.

    ------------------------------
    Ken Rose
    CSSi LifeSciences
    Glen Burnie, MD
    United States
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  • 2.  RE: INTERACT Meetings with Sponsors for Drugs and Biological Products

    Posted 12-Nov-2020 07:33
    Hi Ken,

    To me the SOPP seems pretty clear that the meeting request and background information are to be submitted together by email (Section B) and pretty well describes the content of the package. It will be interesting to hear from others whether this was not sufficient in the end or did not result in a successful discussion.

    ------------------------------
    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 3.  RE: INTERACT Meetings with Sponsors for Drugs and Biological Products

    Posted 12-Nov-2020 09:45

    Hi Glen,

    You are absolutely correct.  My eyes jumped right over Item 1 and went straight to Item 3.  Thank you!  I'll check with the PM to see if we can submit via NextGen like we can with Pre-IND meeting requests.  I feel better submitting via a portal whenever it is possible.



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    Ken Rose
    Painesville OH
    United States
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    Original Message


  • 4.  RE: INTERACT Meetings with Sponsors for Drugs and Biological Products

    Posted 12-Nov-2020 12:50
    Hi Ken,

    Look at page 3 of SOPP 8214:  PDF format emailed to INTERACT-CBER@fda.hhs.gov

    BTW, NextGen is only for CDER, not CBER.

    Best regards,
    Pam

    ------------------------------
    Pamela Larson
    Associate Director, Regulatory Affairs
    San Diego CA
    United States
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    Original Message


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