Monthly Archives: October 2012

Puzzle Pieces

Posted on October 30, 2012 by Jennie Spotila

Let’s play a game. Imagine you have a large puzzle that makes an Impressionist picture of a colorful cottage-style garden. You can put it together as long as you have the picture on the box. First you assemble the lower … Continue reading →

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Patient Focused Drug Development

Posted on October 25, 2012 by Jennie Spotila

The FDA hosted a public meeting this morning to discuss the Patient Focused Drug Development (PFDD) initiative. The meeting was available via webcast, and a transcript will be published on the FDA website. CFS is on the list of candidate … Continue reading →

Posted in Advocacy, Research | Tagged , , , , , , , | 7 Comments

Mary Dimmock’s Comments to the FDA

Posted on October 25, 2012 by Jennie Spotila

Mary Dimmock presented a shortened version of these comments at the FDA meeting today on the Patient Focused Drug Development initiative. She has kindly given me permission to post her comments in full here. My name is Mary Dimmock and … Continue reading →

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FDA Input Sought

Posted on October 20, 2012 by Jennie Spotila

As part of its commitment under the recently approved Prescription Drug User Fee Act (PDUFA V), the FDA will be conducting an initiative, called the patient-focused drug development initiative, to provide for a more systematic approach to obtain the patient’s … Continue reading →

Posted in Advocacy | Tagged , , , , , | 7 Comments

This. Is. Why.

Posted on October 17, 2012 by Jennie Spotila

I’m on the verge of tearing my hair out, and I suspect I’m not the only one. The American Academy of Family Physicians published a review article about CFS (paywall) on Monday, accompanied by a patient information sheet. From the … Continue reading →

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Blaze of Glory

Posted on October 16, 2012 by Jennie Spotila

Pacing is . . . actually, my descriptions of pacing generally involve expletives that are not appropriate for this blog, so we’ll stick with “Pacing is challenging.” One positive side effect of my pacing efforts, though, is that I am … Continue reading →

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Another CFSAC Done Gone

Posted on October 6, 2012 by Jennie Spotila

The CFS Advisory Committee held its second meeting of the year on October 3-4, 2012. Last time, I organized my summary around the good, the bad, and the WTF moments. This time, I am organizing around the discussion themes. Overall, … Continue reading →

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Metrics

Posted on October 3, 2012 by Jennie Spotila

I delivered the following testimony via telephone to the CFS Advisory Committee on October 3, 2012. I would like to note something that Dr. Nancy Lee said today: “Nothing about me without me.” That’s what we’re asking for. FDA is … Continue reading →

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Meeting This Week

Posted on October 1, 2012 by Jennie Spotila

UPDATE: You can watch the meeting via webcast OR you can call in to the meeting in listen-only mode at  1-866-761-7202. Passcode: 3117619.   The CFS Advisory Committee will meet on Wednesday and Thursday this week. The registration deadline for attendance … Continue reading →

Posted in Advocacy | Tagged , , , , , , , , , | 5 Comments