Monthly Archives: April 2014

Comment on FDA Draft Guidance

I submitted the following comments to FDA on its Draft Guidance to Industry on ME/CFS Drug Development.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On Wednesday, April 23rd, the FDA hosted a webinar to explain the Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Development Drug Products for Treatment.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This Wednesday, FDA will host an informational webinar about the Draft Guidance to Industry on Drug Development for ME/CFS.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

The Research Recruitment Working Group of the CFS Advisory Committee has been formulating recommendations that could potentially change the direction of ME/CFS research at NIH. Not much time has been spent on it at the last two meetings, but I … Continue reading

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Don’t Silence Yourself

On May 5th, the IOM panel creating new diagnostic criteria for ME/CFS will hold its second public meeting. The only way you can provide input is by submitting written comments, unless you are an invited speaker. I’m here to plead … Continue reading

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Demonstration Planned

May 12th – ME/CFS Awareness Day – is just over a month away. Plans for a demonstration are underway, via Erica Verillo. Erica is organizing a May 12th demonstration at HHS in San Francisco from noon-1 PM in front of … Continue reading

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Congress: We Need An RFA

I am very happy to report that an effort is underway to secure Congressional support for a $7-10 million RFA for ME/CFS funding at NIH. And there is something YOU can do to help! Representative Zoe Lofgren (D-CA) and 10 … Continue reading

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