Archive for drugs

The Chronic Fatigue Syndrome Community Spoke…and the FDA Listened: The FDA’s Evocative “Voice of the Patient’ Document

“CFS and ME is a serious disease or set of diseases for which there are currently no FDA approved therapies” 'Voice of the Patient' Document The FDA's Patient Focused Drug Development Initiative marks the first time the FDA is implicitly including patients narratives and needs into their Read more [...]

Building a National Clinical Trials Research Network for Chronic Fatigue Syndrome – Now

"a large, highly representative electronic data infrastructure for conducting clinical outcomes research. Specifically, this program will promote a more comprehensive, complete, longitudinal data infrastructure" If there's anything the chronic fatigue syndrome community could use right now is Read more [...]

FDA Stakeholders Meeting For Chronic Fatigue Syndrome II: Barriers, Breakthroughs and Possibilities For Drug Development

"What we need in CFS is what I call the development of an innovation supply chain." Bernard Munos started off Day II of the FDA Stakeholders Meeting on Chronic fatigue syndrome (ME/CFS). Bernard Munos is not an FDA guy - he's an independent analyst - really a gadfly of sorts -  with a long Read more [...]

Patients Give FDA the Scoop on ME/CFS in First Day of FDA Stakeholder Meeting

"There's an unmet medical need right here and there has been for a long time"  Bob Miller The first day of the FDA Stakeholders Meeting was like an patient/FDA  roundtable session focusing on what symptoms are worst and what treatments worked best.  It's not clear how much 'actionable' information Read more [...]

Last Chance To Register or Comment Plus Surveys and Webinars Galore for Chronic Fatigue Syndrome FDA Stakeholders Meeting

Today is the last day for patients to register or provide comments to the FDA Stakeholder Meeting on April 25th/26. This meeting is turning out to be a bigger deal than we knew. Not only will it light a fire under the FDA to get moving on chronic fatigue syndrome but it's also the first of 20 Read more [...]

FDA Stakeholder Meeting For Chronic Fatigue Syndrome (ME/CFS) Set

The FDA Stakeholder Team began an effort in 2011 to accelerate drug development and discovery at the FDA for ME/CFS.  With Chronic Fatigue Syndrome (ME/CFS) the only major disorder without have an FDA approved drug, our first goal was to get the FDA to create a "Stakeholders Meeting' to clear Read more [...]

The Year Ahead in Chronic Fatigue Syndrome (ME/CFS)

We're stuck in the doldrums as the federal level with little funding and little support but that doesn't mean  stagnation. With several major studies wrapping up 2013  will be a very important year for this disorder. Check out some of the events and studies to look forward to this year. FDA Decision Read more [...]
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