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  • 1.  INDs for Different Formulations

    This message was posted by a user wishing to remain anonymous
    Posted 17-Oct-2018 12:05
    This message was posted by a user wishing to remain anonymous

    Dear Members-

    If you currently are studying an IR formulation and there are plans to develop an MR formulation, will a separate IND need to be submitted or can it be combined with the current IND?

    Thank you so much for your help!


  • 2.  RE: INDs for Different Formulations

    This message was posted by a user wishing to remain anonymous
    Posted 17-Oct-2018 13:44
    This message was posted by a user wishing to remain anonymous

    FDA would recommend separate INDs (Cross reference is ok), if ultimately successful, would lead to two separate NDAs.
    Original Message


  • 3.  RE: INDs for Different Formulations

    This message was posted by a user wishing to remain anonymous
    Posted 18-Oct-2018 12:08
    This message was posted by a user wishing to remain anonymous

    ​Recommend that you consult with your reviewing Division's PM first. Some Divisions will allow multiple formulations under the same IND (the regs aren't specific if it has to be a new IND), some won't.
    Original Message


  • 4.  RE: INDs for Different Formulations

    Posted 18-Oct-2018 21:10
    Hello Anonymous,

    You have clearly indicated the type of formulations by specifying you are talking about different dosage forms (i.e. IR vs MR etc not just formulation changes) so I do agree with the previous anonymous response that the FDA requires different INDs for different dosage forms for the same API. Different formulations for the same same dosage form and API can be studied in one IND. Hope this helps.

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    Original Message


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