Regulatory Open Forum

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  • 1.  paper/electronic submission.

    Posted 12-Sep-2012 12:30

    Hi,
    I saw some posts of paper or electronic versions of submission. Now I have a different question to ask. For NDA submission, whether one can submit a part electronically while submit the rest as paper document?
    Such mix & match is allowable?
    Thanks in advance.
    Keya



  • 2.  RE:paper/electronic submission.

    Posted 12-Sep-2012 13:10
    Keya,

    In these type of submission you have to discuss it with your project manager at FDA, usually you have to send the final product labels (12 of each or if they want more) in hard copies and the rest in electronic if you have been sending it electronically before. 

    Sometimes the reviewer asks for desk copy and you have to send it in hard copy followed by electronic copy, but as I mentioned it is very important to talk to your project manager first. 

    Regards, 
    Yasamin


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    Yasamin Ameri RAC
    Consultant
    Quest International Consulting
    Lake Forest CA
    United States
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    Original Message


  • 3.  RE:paper/electronic submission.

    Posted 13-Sep-2012 08:52
    Unless the electronic and / or the paper submission is mandated, you are at liberty to submit in either format
    Siegfried

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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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    Original Message


  • 4.  RE:paper/electronic submission.

    Posted 13-Sep-2012 08:57
    Hi Keya,

    I will strongly say "no" to a mix of paper / electronic submissions.  Once you move to the eCTD process you must continue.  My experience is that you "can" have your NDA / ANDA in paper and leave it in paper format but moving to eCTD format is when the lifecycle changes for the product.  For example, I have worked with ANDAs approved in the 70's.  We submitted supplements in eCTD format without the entire ANDA being converted to electronic format.  I thought there was a requirement to request a waiver from having the entire ANDA in electronic format if wasn't submitted that way but hopefully others will reply.

    Good luck!  It makes life so much easier for the company. 

    -------------------------------------------
    Alison Trado
    Regulatory Affairs Manager
    Hill Dermaceuticals, Inc.
    Sanford FL
    United States
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    Original Message


  • 5.  RE:paper/electronic submission.

    Posted 13-Sep-2012 10:49
    Hi Keya,

    Let me follow-up with another approach.  When you submit your annual report in hard copy you can submit your labeling in electronic format as per 21 CFR 314.81(b)(2)(iii)(b). 

    Working with your project manager, as posted from another in this discussion, is a good approach. 

    -------------------------------------------
    Alison Trado
    Regulatory Affairs Manager
    Hill Dermaceuticals, Inc.
    Sanford FL
    United States
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    Original Message