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  • 1.  Annual report question

    Posted 30-Jun-2017 12:04
    Hello Everyone,
    Where would I find unpublished reports to include as part of an Annual Report?

    Thanks,

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    Sarah Green
    Cyclomedical International Inc.
    Knoxville TN
    United States
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  • 2.  RE: Annual report question

    Posted 01-Jul-2017 13:56
    ​What kind of annual report?  To whom?

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: Annual report question

    Posted 05-Jul-2017 08:14

    Good question ... most likely source is your own company and its connections with users, docs, etc. Just make sure that they are credible documents.

    Art

     




    Original Message


  • 4.  RE: Annual report question

    Posted 06-Jul-2017 14:43
    I am assuming you mean a PMA annual report based on the wording you used. In which case it is generally things your company would already be aware of:

    - posters and podium sessions at big (and small) society meetings
    - internal research - say by a research group
    - external "basic" research - say from grants your company gives to outside researchers
    - unpublished data from registries etc that the company has knowledge of

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


  • 5.  RE: Annual report question

    Posted 13-Jul-2017 16:52
    On Form 2252 under Type of Information there is a section for clinical data (f).  From what I've seen from our consultant there are, when applicable, published and unpublished reports listed in the annual report in module 1.13.2.  I'm curious where to find unpublished reports for Ammonia N 13 Injection, USP and other radiopharmaceutical drugs.

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    Sarah Green
    Cyclomedical International Inc.
    Knoxville TN
    United States
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    Original Message


  • 6.  RE: Annual report question

    Posted 14-Jul-2017 20:32
    Sarah,
    I believe Ginger answered your question above. There won't be a repository of unpublished reports. "Aggressive googling" is probably the best strategy. I'd also advise looking at the major conferences for your industry to see if there were poster presentations/abstracts that could be related. Document how you did your search to show that due diligence was done. There is no way to capture all unpublished information, but it could be helpful to see if there is a signal related to your product.

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    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
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    Original Message


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