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Pre-IND meeting Request

  • 1.  Pre-IND meeting Request

    This message was posted by a user wishing to remain anonymous
    Posted 06-Nov-2020 16:42
    This message was posted by a user wishing to remain anonymous

    Hello,

    I am looking to submit a Pre-IND meeting request to CDER at FDA. This does not include the briefing package as it is only a meeting request. Can someone please let me know if I can submit the meeting request via email. If yes, what should be the email address? If no, what are my options?

    Thank you in advance!


  • 2.  RE: Pre-IND meeting Request

    Posted 09-Nov-2020 08:01
    Per the December 2017 Guidance on PDUFA meetings, a meeting request may be submitted by email but only as a courtesy copy. The official request has to be submitted on paper or electronically through the electronic submission gateway. The appropriate email address can be found for the review division to which you are submitting the request. If you have not had any contact there yet, contact the head project manager for the Division. You can find the information at https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder.


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

    Original Message


  • 3.  RE: Pre-IND meeting Request

    Posted 09-Nov-2020 08:33
    Hello,

    Per the FDA Guidance on Formal meetings between FDA and Sponsor: 

    "When a meeting is needed, a written request must be submitted to the FDA via the respective center's document room (paper submissions) or via the electronic gateway, as appropriate. Requests should be addressed to the appropriate review division or office and, if previously assigned, submitted to the application (e.g., investigational new drug application (IND), new drug application (NDA), biologics license application (BLA)). Meeting requests sent by fax or email are considered courtesy copies only and are not a substitute for a formal submission."

    Best Regards,


    ------------------------------
    Charlene Revel
    Senior Regulatory Scientist
    Cambridge MA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Pre-IND meeting Request

    Posted 09-Nov-2020 08:34
    Edited by Bridgette Kunst 09-Nov-2020 08:54
    CDER accepts pre-IND meeting requests and briefing packages in PDF format via CDER NextGen Portal under FDA Alternate Submission.
    Here is a link: https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=openid%20profile&state=2113320011_1604928582724&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2Fedmrp

    Good luck!

    ------------------------------
    Bridgette Kunst RAC, MA
    Managing Director
    bkunst@bridgereg.com
    ------------------------------

    Original Message


  • 5.  RE: Pre-IND meeting Request

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

    Thank you very much everyone. We used CDER NextGen portal for the Pre-IND submission.
    Original Message


  • 6.  RE: Pre-IND meeting Request

    This message was posted by a user wishing to remain anonymous
    Posted 27-Mar-2023 08:36
    This message was posted by a user wishing to remain anonymous

    Hi Everyone, I need to submit a pre-IND meeting request to CBER. Please let me know if CBER accepts via the NextGen portal?  Or does it have to be via the electronic gateway?

    Thanks in advance.


    Original Message


  • 7.  RE: Pre-IND meeting Request

    Posted 27-Mar-2023 10:24

    CBER accepts pre-IND meeting requests via DCC email or electronic gateway. The CBER Document Center (DCC) email is CBERDCC_eMailSub@fda.hhs.gov

    For more information, refer to the OTP Learn presentation "OTP Processing of Formal Meeting Requests" - https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otp-learn 

    Good luck!



    ------------------------------
    Bridgette Kunst RAC, MA
    Managing Director
    bkunst@bridgereg.com
    ------------------------------

    Original Message


  • 8.  RE: Pre-IND meeting Request

    This message was posted by a user wishing to remain anonymous
    Posted 28-Mar-2023 08:46
    This message was posted by a user wishing to remain anonymous

    Thank you! May I ask the following please, for Vaccine IND.  Unfortunately, the link is giving an error message "...currently unavailable...". 

    • For the meeting package, the submission can not be via email and has to be via the ESG -- is that correct?
    • Does CBER  grant pIND # via email request, or is it a one time STN?
    • Would any one have a template/example for a pre-IND meeting package, with proprietary info removed. I found university examples online, but I am looking for commercial IND.

    Thanks


    Original Message


  • 9.  RE: Pre-IND meeting Request

    This message was posted by a user wishing to remain anonymous
    Posted 28-Mar-2023 08:47
    This message was posted by a user wishing to remain anonymous

    Thanks so much!  Would any one have a template/example for a pre-IND meeting package, with proprietary info removed. I found university examples online, but I am looking for commercial IND.


    Original Message


  • 10.  RE: Pre-IND meeting Request

    Posted 29-Mar-2023 05:33

    Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants Section VII.C addresses the recommended content of the briefing book. Also, I strongly recommend including a TPP for the product, so the agency has an idea of what you specifically want to achieve for the marketed product. The guidance Target Product Profile - A Strategic Development Process Tool  is highly useful for this purpose.



    ------------------------------
    Arvilla Trag RAC
    Principal Consultant
    CMC Compliance Services
    Iron River MI
    United States
    ------------------------------

    Original Message


  • 11.  RE: Pre-IND meeting Request

    This message was posted by a user wishing to remain anonymous
    Posted 31-Mar-2023 08:25
    This message was posted by a user wishing to remain anonymous

    Thank you for the response!


    Original Message


  • 12.  RE: Pre-IND meeting Request

    This message was posted by a user wishing to remain anonymous
    Posted 03-Apr-2023 08:02
    This message was posted by a user wishing to remain anonymous

    TPP is not required and if I am correct, it has been deleted from the FDA site! I personally agree that TPP is just a waste of time and should be kept internally with the company's drug development team


    Original Message


  • 13.  RE: Pre-IND meeting Request

    Posted 03-Apr-2023 08:39

    I did not say TPP are required, I strongly encouraged their use. I did not find any indication online that the TPP guidance has been withdrawn. I did find an interesting CBER webinar on TPP:
    www.https://fda.yorkcast.com/webcast/Play/a53d0d5863244464b000249f1ddc9fd31d

    I also found a very good article on ways to supplement and improve the functionality of a TPP: 
    Target product profile: a planning tool for the drug development

    MOJ Bioequivalence & Bioavailability remove preview
    Target product profile: a planning tool for the drug development
    Drug development is a very expensive and time consuming process. Industries develop a tool known as Target Product Profile (TPP), which is simply a planning tool for the development of a drug candidate from discovery to clinical development programs. This establishes safety, efficacy, and marketing suitability of the drug.
    View this on MOJ Bioequivalence & Bioavailability >

    .
    When a sponsor does not make clear to FDA what they are attempting to achieve with indication, dosage form, dosing regimen, and many other elements of new drug development, the lack of communication only harms the sponsor, not the agency. A TPP is a living document that changes frequently and is never interpreted by FDA as engraved in stone. It also helps to show a sponsor where their preliminary plans are missing key pieces. If you are not comfortable sharing a TPP with the agency, then don't. There is no risk associated with sharing a TPP with FDA, but there can be multiple benefits, including potential advice that can save a sponsor time and money. 



    ------------------------------
    Arvilla Trag RAC
    Principal Consultant
    CMC Compliance Services
    Iron River MI
    United States
    ------------------------------

    Original Message


  • 14.  RE: Pre-IND meeting Request

    Posted 03-Apr-2023 15:59
    Edited by Edwin Bills 03-Apr-2023 16:05



    Original Message


  • 15.  RE: Pre-IND meeting Request

    Posted 12-Dec-2023 05:45

    Hi mam,

    Can we submit pre-IND meeting request  through nexgen in current scenario ?

    Regards,

    Sapna



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

    Original Message


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