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  • 1.  Guidance for Post marketing Pediatric study

    Posted 11-Dec-2023 04:50

    Dear All,

    For approved NDA,Can postmarketing pediatric study can be performed outside USA?

    Is there any specific guidance need to follow/applicable for pediatric study performed outside USA?

    Regards,

    Sapna



    ------------------------------
    sapna rathi
    Regulatory specialist
    AHME
    India
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  • 2.  RE: Guidance for Post marketing Pediatric study

    This message was posted by a user wishing to remain anonymous
    Posted 12-Dec-2023 09:04
    This message was posted by a user wishing to remain anonymous

    Pediatric study can be performed anywhere as long as the study meets the ICH/GCP, as well as FDA's study requirements such as age, design, targeted population etc!


    Original Message


  • 3.  RE: Guidance for Post marketing Pediatric study

    Posted 13-Dec-2023 05:39

    Hello Sapna,

    I don't know what indication your study is but many companies try to allow in their protocols to recruit paediatric patients as part of their main study with adults. This could help you to gather the data quicker and more cost-efficient than setting up a separate clinical trial. But again I don't know what type of indication this is.

    Good luck with your study. It is very good to consider paediatric patients because there is a great need of treatment options for childhood diseases.

    Olga



    ------------------------------
    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
    ------------------------------

    Original Message


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