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  • 1.  EOP2 meeting

    This message was posted by a user wishing to remain anonymous
    Posted 09-Dec-2020 17:04
    This message was posted by a user wishing to remain anonymous

    For the Type B EOP2 meeting of package, what is the average number of questions to be asked? What is the maximum number you have ever heard about?


  • 2.  RE: EOP2 meeting

    Posted 10-Dec-2020 16:24
    There is no easy answer to your question as the number of questions depends on the complexity of the development program, the novelty of the drug and/or indication, and what advice you need from FDA. It may also depend on whether you have a separate CMC meeting.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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  • 3.  RE: EOP2 meeting

    This message was posted by a user wishing to remain anonymous
    Posted 10-Dec-2020 17:18
    This message was posted by a user wishing to remain anonymous

    No limit, however if you pack both CMC and non-cmc questions in one package and if they are too many CMC related, you may be requested to have a separate meeting for CMC only or split the meetings.


  • 4.  RE: EOP2 meeting

    This message was posted by a user wishing to remain anonymous
    Posted 11-Dec-2020 16:53
    This message was posted by a user wishing to remain anonymous

    I agree with the other responders. There is no formal limit to the number of questions you can ask. They will provide written answers to your questions if you have provided them with sufficient information in the briefing package for them to respond. To minimize confusion and frustration on the part of the Agency, carefully review your prior correspondences and limit the questions to those that are truly impactful for the program (i.e., don't ask them something that they have previously answered unless circumstances have materially changed and the topic warrants another discussion). Also remember that the timing of those responses can be very late, which can make preparing for the actual meeting tricky. Sometimes, divisions won't provide their responses until the day of the meeting, and so you may need to scramble to figure out which ones have been adequately addressed and which ones still require discussion. You will want to have prepared your positions for those discussions well in advance, so the fewer that you need to work on, the more effective the meeting will be.

    I also agree that if CMC is not currently a large area of concern and you feel that your process is not absolutely locked-down, maybe hold the CMC questions and have a separate meeting for those. Unless you have Breakthrough status or something that grants you additional time with the Agency, make judicious use of your time - don't have them bundle your EOP CMC meeting with the regular EOP2 meeting and lose an hour of their time!