Regulatory Open Forum

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  • 1.  Question on CDER Next Generation Portal

    This message was posted by a user wishing to remain anonymous
    Posted 15-Jun-2021 17:05
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,

    I wanted to ask if any one has experience using the CDER Next Generation Portal. Can we submit our Promotional material submissions  through CDER Next Generation Portal even if we are submitting this through ESG?

    Any experience story would be much appreciated.


  • 2.  RE: Question on CDER Next Generation Portal

    Posted 16-Jun-2021 09:22
    Edited by Megan Eddleman, RAC 16-Jun-2021 09:22
    Hi there, 

    The following is an available option upon logging into the NextGen Portal. Currently, you still can submit AdPromo through the NextGen Portal, but on June 24th, 2021, 2253 and Accelerated Approval Presubmissions are required to be submitted through ESG.

    Megan Eddleman, RAC

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    Megan Eddleman
    Sr. Director, Regulatory Affairs
    San Diego CA
    United States
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