Tag Archives: treatment

Drug and FDA News, June 2013

Posted on June 28, 2013 by Jennie Spotila

We’ve had a good discussion in the comments on the advocacy action to request another meeting with FDA. I asked FDA if they would be pursuing Guidance to Industry on ME/CFS drug development, and was told it is already underway. … Continue reading →

Posted in Advocacy | Tagged , , , , | 1 Comment

Precision Is Required

Posted on June 25, 2013 by Jennie Spotila

Post updated June 28, 2013. See end of post for additional information from FDA. Five ME/CFS advocates recently sent a letter to DHHS, FDA and select members of Congress requesting that FDA convene a second meeting with ME/CFS patients “to … Continue reading →

Posted in Advocacy, Commentary | Tagged , , , , , , , | 20 Comments

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 →

Posted in Research | Tagged , , , , , , , | 4 Comments

Patient Representative

Posted on May 6, 2013 by Jennie Spotila

As of today, I have been appointed to the FDA’s Patient Representative Program. This has actually been in the works for awhile, and I’ve been anxious to tell you about it, but it finally becomes official today. The FDA Patient … Continue reading →

Posted in Advocacy | Tagged , , , , , | 15 Comments

Start as You Mean to Go On

Posted on April 25, 2013 by Jennie Spotila

I’m not sure which way to describe the ME/CFS community reaction to the announcement that Kim McCleary will be leaving the CFIDS Association: that people were so stunned you could hear a pin drop or that the news was the … Continue reading →

Posted in Commentary | Tagged , , , , , | 11 Comments

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 →

Posted in Advocacy | Tagged , , , , , , , , , , | 2 Comments

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 →

Posted in Advocacy | Tagged , , , , , , | Comments Off on Learning About FDA

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 →

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

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 →

Posted in Advocacy | Tagged , , , , , , , | Comments Off on FDA Deadlines

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 →

Posted in Advocacy | Tagged , , , , , , , | 2 Comments