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  • 1.  EUA experience for COVID-19 products

    This message was posted by a user wishing to remain anonymous
    Posted 30-Apr-2021 17:21
    This message was posted by a user wishing to remain anonymous

    Hi,
    Does anyone have experience with the EUA pathway, FDA interactions, data requirements etc. for COVID-19 therapies? If you are willing to discuss this, please let me know.

    Thanks.


  • 2.  RE: EUA experience for COVID-19 products

    Posted 01-May-2021 00:59
    Yes. I have been obtaining eua's

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    Robert Di Tullio
    President
    Di Tullio Consulting, Inc.
    La Quinta CA
    United States
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    Original Message


  • 3.  RE: EUA experience for COVID-19 products

    Posted 03-May-2021 17:28
    Please feel free to reach out to me jellis@orielstat.com regarding EUA pathway experience. Thank you

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    joel ellis
    Oriel STAT A MATRIX - ENTERPRISE
    Union NJ
    United States
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    Original Message


  • 4.  RE: EUA experience for COVID-19 products

    Posted 04-May-2021 06:38
    Hi
    Very positive experience, but pathway can be swamped and it is not always clear when your product has been de-prioritized.
    Works best when you have a product FDA wants and it fits a published template.
    For a novel use and/or modification to an existing product, extending a 510[k] can be quicker, particularly if you talk to FDA first.
    Best of luck!
    Neil

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    Neil Armstrong FRAPS
    CEO MeddiQuest MeddiQuest Limited
    MeddiQuest
    Peterborough
    United Kingdom
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    Original Message


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