Tag Archives: DHHS

Speeding Things Up

Posted on December 10, 2012 by Jennie Spotila

In my previous post, I explained the definitions FDA used to determine that CFS is a serious or life-threatening condition. But the true significance of FDA’s decision is that it makes CFS treatments eligible for programs that speed up the … Continue reading →

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Serious Or Life-Threatening

Posted on December 6, 2012 by Jennie Spotila

During the stakeholder teleconference with FDA on September 13, 2012, Dr. Sandra Kweder said that FDA considers ME/CFS to be a serious or life-threatening condition. In the world of FDA regulations, this is a very important designation. Here’s the full … Continue reading →

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FDA Webinar on Advocacy

Posted on November 16, 2012 by Jennie Spotila

Yesterday, the FDA hosted a webinar for the ME/CFS community on “Working Together for Change.” Their stated goal was to show what has been successful for patient groups in the past in working with FDA and other entities. The slides … Continue reading →

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CFSAC Testimony of Dr. Joan Grobstein

Posted on November 8, 2012 by Jennie Spotila

Dr. Joan Grobstein delivered these comments to the CFS Advisory Committee at its October 3-4, 2012 meeting. She has kindly given me permission to publish them here. Hello.  I’m Dr. Joan Grobstein.  I’m a physician. My topic is responsibility. Recently … Continue reading →

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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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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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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 →

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Those Lipkin Samples

Posted on September 22, 2012 by Jennie Spotila

You may recall from my post on the Lipkin study that Dr. Lipkin talked about the sample cohort at the press conference on September 18th. Dr. Lipkin said that the samples would be available for other investigators and that applications … Continue reading →

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