Regulatory Open Forum

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  • 1.  ESG WebTrader Account upgrade

    Posted 08-Aug-2017 11:24
    ​Hi all,

    I have already installed a previous version of the WebTrader client, and need to upgrade it now.
    I've followed the steps from FDA Electronic Submission Gateway New WebTrader Tutorial and I was able to submit a test and I got both a receipt and acknowledgement for the new WebTrader in Pre-Production.

    1. Does anybody knows if I can consider my testing as being completed successfully? Or will I receive a feedback from FDA for moving into production?
    2. Until FDA moves the gateway into production (between Aug 14th and Sep 14th), can we still use the current (old) platform for submissions?

    Thanks and Kind Regards,
    Claudia

    ------------------------------
    Claudia Meneghisse PHD, RAC
    Senior Regulatory Affairs Manager
    Tecan Schweiz AG
    Männedorf
    Switzerland
    ------------------------------


  • 2.  RE: ESG WebTrader Account upgrade

    Posted 08-Aug-2017 12:42
    I'm including a copy of the response from FDA regarding my similar question on the updated WebTrader client and receipt/acknowledgement:

    On 7/21/17, at 3:08 pm, HELP DESK wrote:
    Hi John,

    ... The .txt is the only receipt/acknowledgement that you will receive for submissions that are sent to Gen2. According to our system, this receipt/acknowledgement has been delivered. Please let us know if you need additional assistance. Thank you.







  • 3.  RE: ESG WebTrader Account upgrade

    Posted 11-Aug-2017 09:37
    ​Thanks John!

    Kind Regards,
    Claudia

    ------------------------------
    Claudia Meneghisse PHD, RAC
    Senior Regulatory Affairs Manager
    Tecan Schweiz AG
    Männedorf
    Switzerland
    ------------------------------