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Is it required to get a new IND for a new indication?

  • 1.  Is it required to get a new IND for a new indication?

    Posted 17-Feb-2021 23:08
    Dear All,

    May I ask some advice for - "Is it required to get a new IND for a new indication?" 

    Best regards,

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    YIHUI LIU
    杭州市
    China
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  • 2.  RE: Is it required to get a new IND for a new indication?

    Posted 18-Feb-2021 03:32
    From my experience, CBER requires the opening of a new IND for each new indication, even if it is the same medicinal product.

    it is possible to cross refer between different sections of the INDs to lower the burden of submission.

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    Yaron Ramati
    Tel Aviv
    Israel
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    Original Message


  • 3.  RE: Is it required to get a new IND for a new indication?

    Posted 18-Feb-2021 20:55
    Thank you Yaron for your advice. May I have some clue about where to acquire some info towards my question because I am new to RA and got a little bit lost when I met with massive questions. 

    And May I ask you to explain this "it is possible to cross refer between different sections of the INDs to lower the burden of submission.", does it means for the eCTD docs, I need to submitted IND twice for two different indications but can use same sections materials if they are the same.

    Best regards,

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    YIHUI LIU
    杭州市
    China
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    Original Message


  • 4.  RE: Is it required to get a new IND for a new indication?

    Posted 20-Feb-2021 04:21
    Emma

    Best way of knowing whether the division is expecting a new IND to file a cIinical study protocol in a new indication is calling the project manager assigned to the current IND and tell them about your plans, consulting on whether it requires filing a new IND. 

    Regarding cross-referencing - it should be your assessment on what are the eCTD sections that are identical for both indications/protocols and which ones are unique. Most ofen Module 3 sections (Quality), most of Module 4 (non-clinical) can be crossed referenced.

    Suggest you talk to someone who has done that before for more details.

    Hope this helps...

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    Yaron Ramati
    Tel Aviv
    Israel
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    Original Message


  • 5.  RE: Is it required to get a new IND for a new indication?

    Posted 21-Feb-2021 08:52
    Edited by Xiaocong Guo 21-Feb-2021 16:22
    comments deleted-not applicable.


  • 6.  RE: Is it required to get a new IND for a new indication?

    This message was posted by a user wishing to remain anonymous
    Posted 18-Feb-2021 08:42
    This message was posted by a user wishing to remain anonymous

    Respond with the following questions:
    1. Is the proposed new indication is in the same therapeutic area as in the original indication in the initial IND?
    2. For this new indication the dosage form/route of administration same as in the original IND indication (assuming the API is the same)?

    If yes, then it is unlikely you need a new IND.
    Original Message


  • 7.  RE: Is it required to get a new IND for a new indication?

    Posted 18-Feb-2021 20:51
    Thank you very much, it's very helpful. May I ask for some references I can check with if there is any?
    1. Not the same therapeutic area to the original indication, treating completely different disease. 
    2. the API is the same. But the dosage form is a little bit different from animal studies. 

    Best regards,

    ------------------------------
    YIHUI LIU
    杭州市
    China
    ------------------------------

    Original Message


  • 8.  RE: Is it required to get a new IND for a new indication?

    Posted 18-Feb-2021 21:32
    Edited by Narayan Rao 18-Feb-2021 21:39
    As anonymous above pointed out, please be prepared to file a new IND since its a new therapeutic area for the new indication. Most likely modules that you could cross reference is the Module 4 and in Module 3, drug substance section. When you say dosage form is different, is it from capsules to tablets, liquid to solid oral etc??? Or is it no change in dosage form (i.e. capsules to capsules, tablets to tablets etc) but only change in formulation? These are the questions you need to think about and then confirm with the FDA's project manager. I'd strongly recommend to hire a regulatory strategy consultant instead of trial and error and learning on the job to speed up the process. Good luck!

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    GRSAOnline
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    Original Message


  • 9.  RE: Is it required to get a new IND for a new indication?

    Posted 19-Feb-2021 17:54
    Hi Liu,

    You need to submit a new IND for a new indication. Under eCTD, you likely need to provide information in Quality module 3 (new formulation), non-clinical module 4 (additional animal study to show the new formulation has no impact), clinical module 5 (new clinical study protocol) and module 1 administrative information. Yes, it is better to hire some pro to help you on this.


    ------------------------------
    Jingdong Zhu
    Independent Consultant
    Basking Ridge NJ
    USA
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    Original Message


  • 10.  RE: Is it required to get a new IND for a new indication?

    Posted 17-Mar-2021 05:30
    Hi Zhu,

    Thank you very much for the detailed suggestion. And it's very helpful to have an experienced regulatory for consulting. 

    Best regards,
    Emma

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    Emma LIU
    310000
    China
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    Original Message


  • 11.  RE: Is it required to get a new IND for a new indication?

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2021 09:05
    This message was posted by a user wishing to remain anonymous

    Hi Emma,

    The answer to your question is "it depends."  The best course of action is for you to ask the Regulatory Project Manager for your IND.  The answer will depend on the division's review team area.

    I have experienced both situations.  In one situation, I was able to submit for a new indication under the same IND.  We submitted it as a "Protocol Amendment: New Protocol."  In another situation, the Regulatory Project Manager told me that the indication was under a separate FDA review team, so we had to file a new IND for that second indication.

    Again, I believe the best advice is to ask the Regulatory Project Manager for your current IND.

    Good Luck.
    Original Message


  • 12.  RE: Is it required to get a new IND for a new indication?

    Posted 22-Feb-2021 11:56
    As previously pointed out, similar or sub population of an indication in the same therapeutic area with no new dosage form, one could file under the same IND but if its a different therapeutic area, it's certainty that you need to file a new IND and cross refer appropriate sections!

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    GRSAOnline
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    Original Message


  • 13.  RE: Is it required to get a new IND for a new indication?

    Posted 22-Feb-2021 15:23
    Dear Anonymous,

    Interesting to see your reply. My experience seems to say otherwise, namely, for a new indication (e.g., from one cancer to another) within the same review division (e.g., oncology) we still needed to submit a new IND.

    ------------------------------
    Jingdong Zhu
    Independent Consultant
    Basking Ridge NJ
    USA
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    Original Message


  • 14.  RE: Is it required to get a new IND for a new indication?

    Posted 22-Feb-2021 16:06
    Edited by Narayan Rao 22-Feb-2021 16:13
    Similar or sub population means  NSCLC as a primary lung cancer but with ALK mutation is a subset of primary lung cancer (orphan) so no new IND but rather new protocol as Protocol amendment. Sometimes people defines new indication loosely in oncology, the above specific example is also considered new indication but its actually a sub set/population of NSCLC which is an Orphan indication but comes under the same primary indication NSCLC. 

    From one primary NSCLC to another primary indication say Breast cancer with a new dosage form or any major variation (i.e. tablets to injectable) - New IND

    The other reason that the FDA may ask you to submit a new IND could be purely for administrative reasons, this also happens but rarely.

    Agree?

    If the above original question is in oncology then there are several things that the FDA would look into for requesting a separate IND or not and that's the reason I would suggest to hire an experienced regulatory strategist in Oncology for guidance instead of wasting time on this forum especially with no details provided!!!
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    GRSAOnline
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    Original Message


  • 15.  RE: Is it required to get a new IND for a new indication?

    Posted 22-Feb-2021 22:14
    Dear Narayan,

    I basically agree with your comments. It is usually required to have a new IND when changing the indication even within the same review division. Exception might exist to this usual scheme and the original question was asked vaguely without all the details to justify the exception. It is therefore best answered under the usual scheme, not the exception.

    Gene

    ------------------------------
    Jingdong Zhu
    Independent Consultant
    Basking Ridge NJ
    USA
    ------------------------------

    Original Message


  • 16.  RE: Is it required to get a new IND for a new indication?

    Posted 22-Feb-2021 22:38
    Edited by Narayan Rao 22-Feb-2021 22:44
    Hi Mr. Zhu:
    Emma clearly clarified with the following : "Not the same therapeutic area to the original indication, treating completely different disease"

    Therefore I'd say the above situation requires new IND.

    My response and examples were meant for the anonymous who responded with the following:

    "I have experienced both situations.  In one situation, I was able to submit for a new indication under the same IND.  We submitted it as a "Protocol Amendment: New Protocol."  In another situation, the Regulatory Project Manager told me that the indication was under a separate FDA review team, so we had to file a new IND for that second indication."

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    GRSAOnline
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    Original Message


  • 17.  RE: Is it required to get a new IND for a new indication?

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2021 08:33
    This message was posted by a user wishing to remain anonymous

    I stand by my advice that before embarking on a new IND, the best course of action is to ask for guidance from the Regulatory Project Manager.  It will probably be the case that a new IND is required, but this is not 100% certain. It has been my experience that the RPMs are very helpful.  This path of asking for advice is not only a time-saver, but also helps to develop a nice collaborative relationship with FDA.  Additionally, it is easy and there is no cost to seeking this guidance.
    Original Message


  • 18.  RE: Is it required to get a new IND for a new indication?

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2021 12:35
    This message was posted by a user wishing to remain anonymous

    Good points from all but I do wish to say that the decision as to requiring a new IND or not for a new indication has a rationale behind it and its not arbitrary from the FDA perspective with a few exceptions as pointed above sometimes they do for administrative reasons! One should have their own justification whether to seek a new IND or not first, then confirm with the FDA's PM of their rationale before submitting and filing!
    Original Message


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