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  • 1.  PREA's Full Pediatric Waiver

    This message was posted by a user wishing to remain anonymous
    Posted 20-Apr-2020 12:36
    This message was posted by a user wishing to remain anonymous

    Dear Forum,

    I am unable to locate the list of indications that qualify for a full pediatric waiver on the FDA website.  Does anyone have the link to this information?

    Thank you for your help!


  • 2.  RE: PREA's Full Pediatric Waiver

    Posted 21-Apr-2020 06:15
    Hello - you can find that list here https://www.fda.gov/media/101440/download.  It is a link that's available on FDA's PREA page here https://www.fda.gov/drugs/development-resources/pediatric-research-equity-act-prea

    hope that helps.
    ​

    ------------------------------
    Kimberly Belsky
    Head of Regulatory Policy and Intelligence, Mallinckrodt Pharmaceuticals
    New Jersey
    United States
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    Original Message


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