Regulatory Open Forum

 View Only

  • 1.  Pediatric Plan / Pediatric Written Request

    This message was posted by a user wishing to remain anonymous
    Posted 18-May-2020 15:41
    This message was posted by a user wishing to remain anonymous

    Dear Forum,

    Our company needs to submit the Initial Pediatric Plan in the next couple of months.  If we plan to also decide to request a written request does that have to be included in the plan or can the written request be submitted at a later date?

    Thank you for your advice it is greatly appreciated.


  • 2.  RE: Pediatric Plan / Pediatric Written Request

    Posted 19-May-2020 05:10
    The Written Request is the document issued by FDA not the sponsor. A sponsor may request to revise a Written Request once issued. The sponsor submits an initial PSP. Once FDA agrees to PSP they will ask sponsor to submit agreed PSP. These steps and more are detailed in the 2016 Pediatric Study Plan guidance.

    ------------------------------
    Timothy Kline, Ph.D., RAC
    ------------------------------

    Original Message


  • 3.  RE: Pediatric Plan / Pediatric Written Request

    Posted 19-May-2020 08:44
    A request for a Written Request can be submitted any time, keeping in mind that the request and FDA response needs to be initiated early enough that the study reports can be submitted and evaluated by FDA before patent or exclusivity expiration. Otherwise, pediatric exclusivity cannot be awarded.

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

    Original Message


  • 4.  RE: Pediatric Plan / Pediatric Written Request

    This message was posted by a user wishing to remain anonymous
    Posted 19-May-2020 10:06
    This message was posted by a user wishing to remain anonymous

    If I understand correctly, you're going to submit a required Pediatric Study Plan (PSP) to satisfy the requirements of the Pediatric Research Equity Act (PREA) and you're also considering whether to submit a Proposed Pediatric Study Request (PPSR) for an optional pediatric exclusivity study. If the FDA agrees with your PPSR proposal, it will issue a written request for the study, and pediatric exclusivity would be granted after the agency accepts the data from the completed study.

    The PPSR can be submitted at any time and many sponsors don't submit one until years after a product is approved. However, there are a number of advantages to coordinating your PPSR with your PREA study. As described in the FDA's guidance, How to Comply with the Pediatric Research Equity Act, in some instances the agency will allow a PREA study to count as a pediatric exclusivity study. The FDA has allowed this less frequently in recent years, but coordinating the two studies can still make enrollment much more efficient, reduce costs, provide opportunities for extrapolation from the PREA studies, avoid future unnecessary study in children, etc. So, to the extent that you can coordinate the PSP and the PPSR to propose overlapping studies, it's a good idea to do so.


    Original Message


  • 5.  RE: Pediatric Plan / Pediatric Written Request

    Posted 19-May-2020 12:38
    Agree 100% with the anonymous response above.

    However your question: "If we plan to also decide to request a written request does that have to be included in the plan or can the written request be submitted at a later date?"

    You can do separately, in fact it is typical in most cases! There are so many elements such as trial design, choice of population/endpoints, dosage form etc coordinating together will be a challenge unless you have a real strategic advantage and willing to invest in considerable time in this coordination effort.


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

    Original Message


Related Content