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  • 1.  Informal Meetings with CDER

    This message was posted by a user wishing to remain anonymous
    Posted 31-May-2022 09:50
    This message was posted by a user wishing to remain anonymous

    Hello!

    I was wondering if a company can request an informal meeting with CDER to discuss a certain topic (e.g. nonclinical) prior to the pre-IND meeting.

    Thanks for your help!
    Anon


  • 2.  RE: Informal Meetings with CDER

    This message was posted by a user wishing to remain anonymous
    Posted 31-May-2022 11:21
    This message was posted by a user wishing to remain anonymous

    No!
    Original Message


  • 3.  RE: Informal Meetings with CDER

    Posted 01-Jun-2022 05:05

    Dear Anon,

    it is possible but it depends, see the following:  Informal meetings can be scheduled with the FDA, subject to their resource constrains, and represent usually a preliminary, non-binding FDA advice either on general aspects of certain regulatory topics (e.g. informal meetings with the Office of Orphan Products Development-OOPD) or offer a bit more specific preliminary Agency views at an early stage of development prior to a pre-IND meeting (e.g. INTERACT meetings withCBER).

    If you have a good relationship with your PM, you maybe be able to receive preliminary advise to a specific topic with Quality, Clinical and toxicology reviewers. I have done this for various projects and companies.  Again, it depends on workload and topic of interest. If a really unique project, molecule or indication, FDA may engage. 

    So it can't hurt to approach your PM, the worst thing that can happen is no answer, recommendation to request the pre-IND meeting or they can't answer it without more info.


    Good luck,

    Dar

     



    ------------------------------
    Darlene Rosario MBA, RAC
    Principle Consultant
    Ventura CA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Informal Meetings with CDER

    This message was posted by a user wishing to remain anonymous
    Posted 02-Jun-2022 09:44
    This message was posted by a user wishing to remain anonymous

    Thank you so much!
    Original Message


  • 5.  RE: Informal Meetings with CDER

    Posted 01-Jun-2022 08:19
    Yes, but it depends on the nature of the question and what additional information the reviewers would need to answer the question. There are a number of areas at FDA that encourage early discussions. If the question can be answered without extensive review of information, then as Darlene suggests, a good rapport with the RPM can often result in a quick response. Having an actual meeting (telecon, e.g.,) is unlikely as an informal interaction. Often, the RPM will request such simple questions be submitted to the application so that the interaction is documented.

    ------------------------------
    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
    ------------------------------

    Original Message


  • 6.  RE: Informal Meetings with CDER

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jun-2022 10:39
    This message was posted by a user wishing to remain anonymous

    "I was wondering if a company can request an informal meeting with CDER to discuss a certain topic (e.g. nonclinical) prior to the pre-IND meeting."

    An informal meeting prior to a pre-IND meeting: FDA would ask the company to request a pre-IND meeting! If the IND was already active then possibilities that were expressed by Glen and the other consultant would be foreseen but I disagree with their responses in the current FDA environment! In the old school, yes perhaps a possibility! 
    Original Message


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