Tag Archives: FDA

Guidance to Industry

Posted on March 10, 2014 by Jennie Spotila

Last year, the FDA said it would be preparing Guidance to Industry on drug development for ME/CFS and now they have delivered. Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products For Treatment* has been published in draft form, … Continue reading →

Posted in Advocacy, Research | Tagged , , , , | 13 Comments

Exhibit A

Posted on October 17, 2013 by Jennie Spotila

I’ve been very critical of HHS and how they have handled communications and engagement with the ME/CFS patient community, and the fiasco surrounding the Institute of Medicine study is a sinkhole of terrible engagement. But if HHS and/or the IOM … Continue reading →

Posted in Advocacy, Commentary | Tagged , , , , , , , , , , | 8 Comments

Training Wheels

Posted on October 8, 2013 by Jennie Spotila

When the news about the IOM contract first broke on August 27th, I was at my training for FDA Patient Representatives. Here is my much delayed write-up of that training. Every year, the FDA Patient Representative Program holds an in-person … Continue reading →

Posted in Advocacy | Tagged , , , , , , | 18 Comments

Drug and FDA News, August 2013

Posted on August 23, 2013 by Jennie Spotila

Next week, I will be attending the FDA’s Patient Representative Workshop for new patient reps. The meeting is 1.5 days of orientation and discussion, and I am eager to meet my fellow patient representatives. I will report back on the … Continue reading →

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Hypersensitive

Posted on August 13, 2013 by Jennie Spotila

FDA recently issued a warning about the risk of rare but serious skin reactions to acetaminophen. Widely known by the brand name Tylenol, acetaminophen is an active ingredient in many prescription and over-the-counter medicines for pain, headaches, migraine, cold and … Continue reading →

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Drug and FDA News, July 2013

Posted on July 25, 2013 by Jennie Spotila

The big BIG reminder for the ME/CFS community is that the public comment docket on drug development for ME/CFS will close on August 2, 2013. As of this morning, there are only 201 comments! That’s disappointing, given that FDA said … Continue reading →

Posted in Advocacy | Tagged , , , , | 3 Comments

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 →

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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