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  • 1.  CBE-30 Hold time

    This message was posted by a user wishing to remain anonymous
    Posted 07-May-2018 10:42
    This message was posted by a user wishing to remain anonymous

    ​​Can you please share your experience regarding how long do you generally wait after filing CBE-30 to release the batches?


  • 2.  RE: CBE-30 Hold time

    Posted 08-May-2018 08:41
    ​It depends on the CBE-30. If it is absolutely a CBE-30, no question, then we implement after 30-days. If it is a gray area, then we wait 45-days or even better we contact the RPM at FDA and get confirmation that it was accepted as a CBE-30.

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    Cynthia Katsempris
    Director, Regulatory Affairs
    Three Bridges NJ
    United States
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    Original Message


  • 3.  RE: CBE-30 Hold time

    Posted 08-May-2018 10:25
    I agree with Cynthia - how long to wait to implement needs to be a risk-based decision.  One is regulatory risk - how confident are you that the submission is correctly classified as a CBE-30?  The second is a business risk - how confident are you that FDA will not have concerns about the content of the submission?  FDA can come back at any time (even 6 months+) with comments or questions about your submission.  Best case, you hear back from FDA before implementing.

    Best,

    Cathy

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    Catherine Anderson PhD, RAC
    Senior Manager - Regulatory CMC
    Hillsborough NC
    United States
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    Original Message


  • 4.  RE: CBE-30 Hold time

    Posted 08-May-2018 10:50

    I would wait the 30 days. You can also email your FDA RPM as the 30th day approaches informing of your intent to release the batches on day 30. If there is potential for a drug shortage if you don't release the batches I would mention this.

    Tom

    Chicago




    Original Message


  • 5.  RE: CBE-30 Hold time

    This message was posted by a user wishing to remain anonymous
    Posted 09-May-2018 11:48
    This message was posted by a user wishing to remain anonymous

    ​Thank you for your response. I have seen both 30 day & 45 day approach.
    But recently I came across the approach to wait till 60 day (making sure application is good enough for substantive review) even if you receive the acknowledgement letter confirming that the application is CBE30.
    Original Message


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