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A disease with two faces? Re-naming ME/CFS
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Training and Strategy Mtg. for FDA Workshop

Discussion in 'Action Alerts and Advocacy' started by usedtobeperkytina, Apr 4, 2013.

  1. usedtobeperkytina

    usedtobeperkytina Senior Member

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    For those who will be submitting written or give in-person comments at the FDA ME/CFS Drug Development Workshop, we are hosting a strategy and training meeting on line. We have 15 openings, so sign up now: http://conta.cc/Yuun22

    The meeting will be April 5 at 4:30 p.m. EST.

    Tina
     
    Valentijn likes this.
  2. Nielk

    Nielk

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    Can one send in written testimony without actually being able to attend the meeting?
     
  3. Ember

    Ember Senior Member

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    As posted by Bob, Monday is the deadline for written comments to receive consideration:
    Submit a comment: http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0962-0004
     
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  4. Ember

    Ember Senior Member

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    On the government sites soliciting comments, I notice that two different deadlines have been posted, one for Sunday night and the other for Monday night:

    http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0962-0004
    http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0962
    Only 86 comments have been received so far. Those seem to include comments pertaining to last September's teleconference.
     
  5. usedtobeperkytina

    usedtobeperkytina Senior Member

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  6. jspotila

    jspotila Senior Member

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    I made another attempt at explanation today: http://www.occupycfs.com/2013/04/07/down-to-the-wire/

    The docket fro written comments will be open until AUGUST 2ND. FDA has committed to that date in the Federal Register notice and in communications with advocates. I'm not sure why the docket page is saying April 8th, but August 2nd is the real date.
     
  7. Ember

    Ember Senior Member

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    Here again is the relevant quotation:
    The same government document invites comments by midnight on April 7, however:
     
  8. usedtobeperkytina

    usedtobeperkytina Senior Member

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    PANDORA Org and NAAME will be hosting another FDA Workshop Training and Strategy meeting on line at 1 p.m. on April 16. We are providing tips for making successful in-person or written comments to the FDA, the panelists and others attending the ME/CFS Drug Development Workshop. These tips are based on the experience of long-time advocates and suggestions from a drug development researcher.

    Please sign up through this form, and we will send you an invitation to attend the April 16 meeting: https://docs.google.com/forms/d/1CmFksURXKE8P-ESc958XoNfFKMe9P9ByjeWheavMd80/viewf
    The first 25 who sign up will receive the invitation.

    Thanks
     
  9. Nielk

    Nielk

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    The link doesn't work for me.
     
  10. usedtobeperkytina

    usedtobeperkytina Senior Member

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  11. jspotila

    jspotila Senior Member

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    The docket page now reflects the correct deadline of August 2nd.
     
  12. jspotila

    jspotila Senior Member

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    Update: FDA has agreed to accept video testimony in the form of YouTube links submitted through the comment docket.

    Many advocates had hoped FDA was going to accept video comment at the meeting, but FDA declined. In subsequent exchanges with FDA, I emphasized that the most severely ill patients cannot attend the meeting next week and that their views on the worst symptoms and the treatments they have tried were critically important. Personally, I believe it is important for the patients to be seen by policymakers to whatever extent is possible.

    Based on feedback that I and others provided, FDA has agreed to accept and review videos submitted through the docket. If you wish to do this, make a video of yourself and post it to YouTube. FDA has asked people to focus on answering the questions FDA posed in the meeting notice as these will be most helpful to FDA in evaluating drugs moving forward. After you have posted the video to YouTube, you may submit the link through the comment docket. The deadline is August 2nd, so you have time to do this at your own pace.
     
  13. Ember

    Ember Senior Member

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    Would this video of an ME patient's best day be of interest to the FDA?

    During the workshop, a panel of patients and patient representatives will provide comments to start the discussion on Topic 1 -- Disease Symptoms and Daily Impacts That Matter Most to Patients:
    Could reference to this UK portrayal of severe ME symptoms and daily impacts prove useful?
     
  14. jspotila

    jspotila Senior Member

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    Jessica's videos are very powerful. She could certainly submit them in the docket. I don't think others should do that on her behalf, though.

    FDA is most interested in answers to those questions in the meeting notice. There are a variety of ways people can answer them in their videos or written comments. Sticking to those topics will have the biggest productive impact on FDA's review of the docket and subsequent meeting report.
     

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