Archive for FDA

FDA Approval of MS Drug Puts Ampligen Back In Play

Deja Vu? "I just try and not think about it, because it gets me furious" multiple sclerosis patient The story sounds eerily similar. Citing questions regarding study quality and side effects, the FDA refuses to approve a drug for a condition for which few or no effective drugs exist. After hearing 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 Puts the Squeeze on Pain Drugs – Some Fibromyalgia and Chronic Fatigue Syndrome Patients To See Effects

The F.D.A. recommendation is likely to have a significant impact on the availability of the drugs. New York Times Last week FDA's ruling reclassifying narcotic pain relievers such as Vicodin and Lortab which contain hydrocodone combined with acetaminophen as schedule II drugs will make them more difficult Read more [...]

ME/CFS Patients Call To Action: Advocates Call for FDA to Hold ‘Real’ FDA Stakeholder’s Meeting

ATTENTION ME/CFS COMMUNITY We the "FDA Team" are asking you to send the message below to the FDA and to listed members of Congress. The recent patient-focused drug development meeting held by the FDA was a start - but only a start. The FDA stated that their goal was to support treatments 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 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 [...]

Secretary of Health Sebelius Responds to Senate Majority Leader Harry Reid on Chronic Fatigue Syndrome (ME/CFS)

We thank Senate Majority Leader Harry Reid for his longtime work and support for the ME/CFS community, and especially for his recent efforts with the Secretary of Health to stress the serious unmet need in the ME/CFS community and the drastic implications of the FDA's denial of the only medicine in 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 [...]