Regulatory Open Forum

 View Only

  • 1.  IND path for a new dosage form and sensitive population

    This message was posted by a user wishing to remain anonymous
    Posted 29-Mar-2023 06:55
    This message was posted by a user wishing to remain anonymous

    Hi, I wanted to know the IND path if a drug product in an adult population is extended to the children population with a different disease group. Also, can the IND be cross-referenced, and a small clinical study of 5 subjects be done for the children's study?

    Thanks



  • 2.  RE: IND path for a new dosage form and sensitive population

    Posted 30-Mar-2023 05:54

    Dear Anon,

    INDs can be cross-referenced even across Review Divisions, but I'd suggest you confirm that this would be acceptable with the Review Division for the pediatric indication. Whether the Review Division for the pediatric indication would accept a 5-subject study to support the indication needs to be discussed with the Review Division.

    Good luck!



    ------------------------------
    Mark A De Rosch, PhD, FRAPS
    Aura Biosciences, Inc.
    Boston, Massachusetts
    United States
    ------------------------------

    Original Message


  • 3.  RE: IND path for a new dosage form and sensitive population

    Posted 30-Mar-2023 10:01

    If the pediatric indication is related to the adult indication you may be able to conduct under same IND.  If completely different I think you'd need a separate IND.  Yes - you can cross reference from peds IND to adult IND (nonclinical, clin pharm, CMC).



    ------------------------------
    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
    ------------------------------

    Original Message


  • 4.  RE: IND path for a new dosage form and sensitive population

    Posted 30-Mar-2023 11:11
    Edited by Narayan Rao 30-Mar-2023 11:12

    I think what you wish to do is an exploratory IND for children with only 5 subjects. This maybe an option:

    https://www.fda.gov/media/72325/download

    Sure you can cross-reference!



    ------------------------------
    GRSAOnline
    ------------------------------

    Original Message


Related Content