Regulatory Open Forum

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  • 1.  NDA filings

    Posted 17-Nov-2022 15:25
    Should 2.7.6 Synopsis be provided in both a PDF and word version in a NDA filing?

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    Elizabeth Johnson
    Flowery Branch GA
    United States
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  • 2.  RE: NDA filings

    Posted 18-Nov-2022 08:08
    I have never done so, and never been asked to submit a word version..

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 3.  RE: NDA filings

    Posted 18-Nov-2022 09:25
    Edited by Beth Weinberg 18-Nov-2022 09:25
    The only documents I've ever been asked to provide in Word in addition to the PDF are the Pediatric Study Plan and occasionally a Statistical Analysis Plan.  Nothing as part of an NDA.

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    Beth Weinberg
    Regulatory Affairs Lead
    Carmel IN
    United States
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    Original Message


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