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  • 1.  Pediatric Study Plan

    Posted 05-Apr-2013 17:15
    Hello,
    We have been asked by FDA to prepare a Pediatric Study Plan at the end-of-phase 2 meeting.  Because we have no experience with it, I would appreciate some information on how to prepare this Pediatric Study Plan.
    Thanks,
    Best regards,
    Clarisse 

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    Clarisse Stone RAC
    Manager, Electronic Documents
    Galderma R&D
    Cranbury NJ
    United States
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  • 2.  RE:Pediatric Study Plan

    Posted 05-Apr-2013 17:46

    See these links on FDA's website:

    Pediatric Research Equity Act (PREA)

    Pediatric Study Plan Template (PDF - 23KB)11

    PREA Retrospective Review (PDF - 281KB)12
    1/14/2010

    Pediatric Research Equity Act of 2003 (Public Law No: 108-155) (posted 12/16/2003) (PDF - 50KB)13

    Guidance for Industry (Draft): How to Comply with the Pediatric Research Equity Act (posted 9/7/2005) (PDF - 116KB)14


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    Original Message


  • 3.  RE:Pediatric Study Plan

    Posted 05-Apr-2013 20:16
    As for the pediatric study plan, it is pursuant to BPCA ('02), PREA ('03), and FDASIA ('12).

    Under PREA, pediatric studies are required.
    Under BPCA, pediatric studies are optional/voluntary.  
    Under FDASIA, new requirements for pediatric study plan.

    Under FDASIA, sponsors are required to submit a PSP (Pediatric Study Plan) at the end of Phase 2.

    I have compiled some additional information on the subject.  Read more here >>

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    Original Message