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  • 1.  FDA CDER NextGen Portal/Manufacturing Capacity

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jan-2021 09:05
    This message was posted by a user wishing to remain anonymous

    Hi Team,

    As a part of ongoing efforts to support product development and availability in response to the COVID-19 public health emergency, FDA is requesting information from manufacturers being considered for treatment of COVID-19 to develop estimates of current and future manufacturing capacity. FDA has developed a portal for submission of manufacturing capacity data and request these information to be submitted trough the CDER NextGen Portal.

    We have tried to create the template for this submission that would serve to our team to respond and review questions prior submission, and we have not had much success. As you travel trough out the all 4 required sections, different options open up for you, and it is hard to keep up with all "yes/no" options down the road.

    If anyone has an idea if such a submission template/instruction exists, or it is possible to be purchased, I would really appreciate it. Please let me know.

    Thanks


  • 2.  RE: FDA CDER NextGen Portal/Manufacturing Capacity

    Posted 29-Jan-2021 01:07
    Anon, the only guide I've seen is this handy introduction powerpoint.
    https://cdernextgenportal.fda.gov/resource/1601754646000/MC_ReferenceGuides
    ​

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


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