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  • 1.  pre-IND meeting

    This message was posted by a user wishing to remain anonymous
    Posted 14-Aug-2019 14:19
    This message was posted by a user wishing to remain anonymous


    Our product is currently running clinical trials in the EU for Phase 1 and we intend to open a US IND for the Phase 2 studies. We plan to hold a pre-IND meeting with the FDA to discuss the Phase 2 protocol (synopsis) and our development plan with the product. However, following the pre-IND meeting, we may file the Phase 1 protocol to open US sites (but we don't discuss the Phase 1 protocol at all during our pre-IND meeting).

    Do you see any challenges with this approach?

    Thanks in advance for your feedback!

  • 2.  RE: pre-IND meeting

    Posted 15-Aug-2019 10:42
    The biggest challenge I would see is that FDA may not be willing to answer all questions regarding a Phase 2 protocol without Phase 1 information and based on a synopsis only. In my experience FDA is reluctant to talk about details of study design and conduct without a full protocol to review. Without knowing what the questions are regarding the Phase 2 protocol or the type of product you have, it is difficult to be very concrete. I think providing the information on the Phase 1 study is more likely to get you useful feedback from FDA.

    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States

  • 3.  RE: pre-IND meeting

    Posted 16-Aug-2019 11:14

    An unusual exception to this is with "drug delivery training devices" (non-functional simulators used for demonstration and training) are considered by CDER as promotional materials, not devices


    Lee Leichter


    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488



  • 4.  RE: pre-IND meeting

    Posted 16-Aug-2019 14:50
    I agree with Glen! You won't be getting answers for Phase 2 when your package does not contain the information for Phase 2 .

    Loganathan Kumarasamy, MS RAC
    Senior Consultant
    Waukegan IL
    United States