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  • 1.  FAST Track Application

    This message was posted by a user wishing to remain anonymous
    Posted 10-Dec-2019 13:27
    This message was posted by a user wishing to remain anonymous

    Does anyone have a template for a fast track or breakthrough product application?  in addition who has the best templates for purchase for INDs and NDAs eCTD submissions?


  • 2.  RE: FAST Track Application

    Posted 11-Dec-2019 10:35
    You have probably already reviewed, but I have just used the FDA "Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics ".  It describes the general format and  contents of fast track and breakthrough product application.  I do not think you need anymore than that to format an application.

    We use templates from Parexel, previously Liquent, for INDs and NDAs.

    Regards

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    Robert Blanks RAC
    VP, Regulatory Affairs and Quality Assurance
    [Ardelyx]
    Auburndale MA
    United States
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    Original Message


  • 3.  RE: FAST Track Application

    Posted 11-Dec-2019 16:22
    We use Starting Point templates for eCTD.  Includes templates for Fast Track and Breakthrough requests.

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    Tom
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


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