“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 [...]
"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 [...]
"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 [...]
"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 [...]
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 [...]
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 [...]
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 [...]