“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...
“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...
“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...
“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....
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...
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