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  • 1.  Same IND for separate dosage forms

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2023 17:59
    This message was posted by a user wishing to remain anonymous

    Hi everyone,

    Back in 2015 my company was developing a tablet under an IND. We then decided to develop an oral suspension dosage form of the same drug. We were able to do this under the same IND. But when submitting the NDAs, we had to file separate NDAs for each dosage form. I believe this is still the process today, but wanted to double check with industry in case things have changed.

    Thank you



  • 2.  RE: Same IND for separate dosage forms

    Posted 15-Sep-2023 20:03

     Yes indeed!



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