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  • 1.  US FDA Protocol for New Indication: New IND or Existing IND -CFR/Guidance reference needed

    This message was posted by a user wishing to remain anonymous
    Posted 11-Mar-2019 10:57
    This message was posted by a user wishing to remain anonymous

    My company has an open IND with ongoing PMC studies for our Drug.  The Drug has an approved NDA and is commercially available. 

    The company is exploring a new indication for this Drug which will require clinical studies to support a future sNDA/NDA.

    I have advised the company:
    1) if the new indication is similar to our approved indication and if the new indication would be reviewed by the same review division - we should be able to submit the protocol for the study in the new indication to the existing IND,
    - and -
    2) if the new indication is unrelated to the existing approved indication, if the population is significantly different or if the review division will be different the company should open a new IND (noting that applicable non-clinical & CMC information can be referenced to the original IND).

    I am being pressured by management to prove that this approach is appropriate.

    Does anyone have an authoritative reference that describes the conditions for when an existing IND should be used vs when new IND is warranted?  I'm in need of a CFR citation, FD&C Act citation, guidance document, FR posting or some "authoritative source" to provide to my management.

    This is not an Investigator IND - so references to Investigator IND guidances will not suffice.

    TIA


  • 2.  RE: US FDA Protocol for New Indication: New IND or Existing IND -CFR/Guidance reference needed

    Posted 12-Mar-2019 08:39
    I have found this to be division-specific.  I would email the Project Manager and ask their preference.  Is your company worried about maintenance of two INDs with different DSUR dates, etc?  In my experience those things can be negotiated and, like you said, heavily cross-referenced.

    ------------------------------
    Beth Weinberg
    Regulatory Affairs Lead
    Carmel IN
    United States
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    Original Message


  • 3.  RE: US FDA Protocol for New Indication: New IND or Existing IND -CFR/Guidance reference needed

    Posted 12-Mar-2019 08:45
    First, I agree with Beth that the best approach is to contact the PM, which is going to be the most authoritative response to convince your management. I am not aware of any guidances or regulation that will specifically help make the decision.

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


  • 4.  RE: US FDA Protocol for New Indication: New IND or Existing IND -CFR/Guidance reference needed

    Posted 18-Mar-2019 12:00
    Agree with Beth and Glen. We had a similar situation and assumed that the protocol could be submitted to the original IND (similar indication and same review Division), but after reaching out to the RPM, was told to submit a new IND with x-references as you suggested.

    Thanks

    ------------------------------
    Aparna Donti Geddam
    AD, Regulatory Affairs
    Green Brook NJ
    United States
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    Original Message


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