Regulatory Open Forum

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  • 1.  Filing a CBE 30 Days

    Posted 29-Jul-2014 14:50
    Dear Regulatory Colleagues:

    Please advise if you know where (address and person) to file my CBE-30 for my
    ANDA product. I plan to do paper submission as our original ANDA is in paper.

    Thank you,

    Ed Lin

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    Ed Lin
    United Biomedical Inc
    Hauppauge NY
    United States
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  • 2.  RE: Filing a CBE 30 Days

    Posted 30-Jul-2014 14:27
    The amendment (CBE-30) does not have to be paper just because the original submission was in paper format. Contact esub@fda.hhs.gov and they should be able to help you get started. Electronic submissions are faster and more efficient. Hope this helps.

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    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
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    Original Message