Archive for FDA

Is Your Health As Valuable As a College Students? A Call To Action From the ME/CFS Treatment Team

Dear Patient Community: We are asking your help to continue to push for treatments for ME/CFS.  Our ME/CFS Treatment team will continue to work for meetings between the FDA and pharmaceutical companies with the sole purpose of urging them to develop and approve drugs to treat ME/CFS. People Read more [...]

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 [...]

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 [...]

FDA Stakeholder Workshop in Trouble? FDA Disavowal of ME/CFS Expert Sows Concern

The FDA has somehow missed the fact that Dr. Daniel Peterson is an ME/CFS expert clinician/researcher. For over 30 years now, Dr. Peterson has been treating ME/CFS patients in Incline Village, Nevada, with a variety of treatments. Earlier today ME/CFS patients were told that FDA has not invited Dr. Read more [...]

FDA Scientific Stakeholder Workshop Needs Your Input

Dear Patients, Patient’s Loved Ones and Friends, Since I ended my hunger strike, I have learned that the FDA has sent invitations for the ME/CFS scientific stakeholder workshop scheduled for April 25-26th. The FDA hasn’t disclosed who it is inviting, and did not solicit input from patients. You, 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 [...]

FDA Advisory Committee Meeting on Ampligen and Chronic Fatigue Syndrome (ME/CFS) Pt: II: the VOTE and Aftermath

Check out Part I of this series ('FDA Advisory Committee Meeting on Ampligen Pt I: Dueling Presentation Set Stage for Critical Vote') on the Simmaron Foundations Website here  The Vote While the FDA statistical team was highly critical of the drug, the FDA put together a Committee  that Read more [...]