Monthly Archives: April 2014

Comment on FDA Draft Guidance

Posted on April 29, 2014 by Jennie Spotila

I submitted the following comments to FDA on its Draft Guidance to Industry on ME/CFS Drug Development.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

Posted on April 25, 2014 by Jennie Spotila

On Wednesday, April 23rd, the FDA hosted a webinar to explain the Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Development Drug Products for Treatment.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

Posted on April 21, 2014 by Jennie Spotila

This Wednesday, FDA will host an informational webinar about the Draft Guidance to Industry on Drug Development for ME/CFS.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

Posted on April 14, 2014 by Jennie Spotila

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 →

Posted in Research | Tagged , , , , , , , , | 16 Comments

Don’t Silence Yourself

Posted on April 8, 2014 by Jennie Spotila

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

Posted on April 5, 2014 by Jennie Spotila

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

Posted on April 2, 2014 by Jennie Spotila

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 →

Posted in Advocacy, Research | Tagged , , , , , , , , , , | 35 Comments