Tag Archives: drugs

Drug and FDA News, May 2013

Posted on May 30, 2013 by Jennie Spotila

Yesterday, the CFIDS Association formally announced what had been rumored to be on the way: they are preparing to file an Investigational New Drug application. The first step will be a pre-IND meeting with FDA. This kind of meeting is … Continue reading →

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FDA Meeting Materials

Posted on April 22, 2013 by Jennie Spotila

The FDA Drug Development Workshop for ME and CFS is finally here!!! I will be speaking on a panel at the meeting on Friday, and am in frantic preparation mode. I’ve gathered the pertinent materials together in one post to … Continue reading →

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Learning About FDA

Posted on April 11, 2013 by Jennie Spotila

FDA’s decision making process is complex, to say the least. But the more we can learn about the process and how FDA fulfills its mission, the better equipped we will be to participate meaningfully in the upcoming Drug Development Workshop … Continue reading →

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Down to the Wire

Posted on April 7, 2013 by Jennie Spotila

Tomorrow is the big deadline to register for the FDA meeting on Drug Development for ME/CFS. I’m recapping the deadlines and also providing a little more information on how participation will work: If you want to attend the meeting in … Continue reading →

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FDA Deadlines

Posted on April 3, 2013 by Jennie Spotila

Deadlines are coming fast and furious as we enter the home stretch before the FDA meeting on Drug Development for ME/CFS. Here are the key dates: APRIL 8TH: Deadline to register to attend the meeting in person – even if … Continue reading →

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What FDA Wants

Posted on April 2, 2013 by Jennie Spotila

I think it’s clear what ME/CFS patients want to come out of the FDA’s Drug Development Workshop for CFS and ME. We want short, straight lines through the drug development landscape to FDA-approved treatments for our disease. But what does … Continue reading →

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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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