Tag Archives: treatment

Clarity on Comment

Posted on March 28, 2013 by Jennie Spotila

As I said when the FDA formally announced the commenting process for the Drug Development Workshop, the process will be very different from what we’re used to from CFS Advisory Committee meetings. At the CFSAC, we sign up for a … Continue reading →

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Index of FDA Meeting Resources

Posted on March 25, 2013 by Jennie Spotila

One month to go until the FDA’s Drug Development Workshop for ME and CFS! There is a boatload of information that might be helpful to you in preparing for the meeting, even if you will only be watching online. I’ll … Continue reading →

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Two Surveys, Two Opportunities

Posted on March 22, 2013 by Jennie Spotila

In addition to all the ways you can participate in and comment on the upcoming FDA Drug Development for ME/CFS Workshop, you can also participate in two surveys that will collect data for presentation at the Workshop. The CFIDS Association … Continue reading →

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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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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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NIH Collaboration

Posted on December 17, 2012 by Jennie Spotila

The news didn’t make much of a splash, but NIH recently issued a funding opportunity announcement that could benefit people with CFS. This purpose of this funding opportunity is to support “collaborative translational research projects” aimed at turning basic discoveries … 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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