Regulatory Open Forum

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  • 1.  MDUFA Cover sheet

    Posted 20-Mar-2024 11:18

    Anyone else having trouble currently generating a MDUFA cover sheet. We seem to not be able to access the form online and keep receiving an error message that the site is unavailable. I have cleared cache, used edge, chrome and firefox to no avail and attempted on several remote devices. I have not had a response from the helpdesk and my calls go to VM.



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    Steve Baker
    i-SMART Consulting US
    US +1 267 432 1045
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  • 2.  RE: MDUFA Cover sheet

    Posted 23-Mar-2024 15:21
      |   view attached

    Hi Steven,

    I was able to download it from the FDA website: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref=

    Hopefully, you'll be able to open it. Let me know and good luck!

    Carol



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    Carol
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