Tag Archives: FDA

Your Move, HHS

Since the IOM report came out, the patient/advocate online community has been on fire. Everyone is staking out a position. You like the name, or you don’t; you think the definition will work, or it won’t. And I have plenty … Continue reading

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IOM: Report Card

It’s here. A new case definition and a new name. It will take some time for me to get through the 300 page report and prepare a more detailed analysis. But based on the press conference and summary, how did … Continue reading

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Comment on FDA Draft Guidance

I submitted the following comments to FDA on its Draft Guidance to Industry on ME/CFS Drug Development. Please note that there is a 5,000 character limit on electronic comments submitted through regulations.gov, so I sent my comments in by mail. … Continue reading

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FDA Guidance: Doors Open

On Wednesday, April 23rd, the FDA hosted a webinar to explain the Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Development Drug Products for Treatment. FDA briefly reviewed the document and took questions in real time. See my original review … Continue reading

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Guidance from FDA

This Wednesday, FDA will host an informational webinar about the Draft Guidance to Industry on Drug Development for ME/CFS. I hope you can attend and learn more about the Guidance document, because public comments are due May 12, 2014! This … Continue reading

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Silver Platter of Frustration

Yesterday’s CFS Advisory Committee meeting was insane. Wait, maybe the meeting just drove me insane. Or was the whole thing just insanely inane? I don’t even know anymore. Wait a second, hang on. Ok, let me start again. Yesterday’s CFS … Continue reading

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Guidance to Industry

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

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Exhibit A

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

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Training Wheels

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

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Drug and FDA News, August 2013

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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