Tag Archives: FDA

The Burial of ME

Mary Dimmock has published an extraordinary review of the last thirty years of ME history. With her permission, I’ve reported her announcement with the link to the full document below. I highly recommend reading as much of this document as … Continue reading

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Assessing Outcomes

The IOM, P2P and AHRQ reports all pointed out a serious gap in ME/CFS research: the absence of validated ways of assessing clinical outcomes. I have new information about an initiative to change that, and I’ll be speaking about my … Continue reading

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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Comment on FDA Draft Guidance

I submitted the following comments to FDA on its Draft Guidance to Industry on ME/CFS Drug Development.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On Wednesday, April 23rd, the FDA hosted a webinar to explain the Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Development Drug Products for Treatment.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This Wednesday, FDA will host an informational webinar about the Draft Guidance to Industry on Drug Development for ME/CFS.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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