Tag Archives: FDA

Showcase

Posted on March 19, 2013 by Jennie Spotila

The upcoming FDA Drug Development Workshop for ME/CFS will be a showcase for our disease and our patient community. We must prepare now to bring our A game on April 25th-26th. FDA first announced this workshop in the summer of … Continue reading →

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Quick Announcement

Posted on March 18, 2013 by Jennie Spotila

Finally (!) I am able to share the news that I’ve been invited to serve on a panel at the upcoming FDA Drug Development for ME/CFS Workshop. I’ve wanted to announce this for awhile, but panelists were asked not to … Continue reading →

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Tell It To The FDA

Posted on March 15, 2013 by Jennie Spotila

The much anticipated FDA meeting on drug development for ME/CFS on April 25-26th is fast approaching, and your participation is needed! There is a great deal of time set aside for patient input, but the process will work very differently … Continue reading →

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No News is No News

Posted on March 4, 2013 by Jennie Spotila

The ME/CFS advocacy community has been hopping recently, with participation in the FDA meeting on Ampligen, my effort with Public Citizen, and Bob Miller’s hunger strike. We’ve been anticipating some sort of response from HHS, especially in the wake of … Continue reading →

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Ampligen is Not AZT

Posted on February 11, 2013 by Jennie Spotila

In recent weeks, some ME/CFS advocates have been calling for NIH to conduct a clinical trial of Ampligen based on the reasoning that NIH conducted trials of AZT during the early years of the AIDS crisis. Unfortunately, this analogy does … Continue reading →

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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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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 →

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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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