U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is a regulatory commission that oversees food, drugs, medical devices, vaccines, tobacco products and more for the United States. To date, the FDA has not approved any drugs for the use of Myalgic Encephalomyelitis & Chronic Fatigue Syndrome (ME/CFS).

FDA activities on drug development for Myalgic Encephalomyelitis & Chronic Fatigue Syndrome

• Apr, 23, 2014 FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment by Janet Maynard, MD, MP

Webinar

Slides

Follow-up to the April 23, 2014 Webinar - Written Questions and Answers

• Mar 11, 2014, Federal Register Notice of Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment; Availability
• Mar 10, 2014, Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment (12 pages)
• Oct 16, 2013, Chronic Fatigue Syndrome and Myalgic Encephalomyelitis (CFS and ME) Stakeholder Teleconference Transcript of Teleconference
• Apr 26, 2013, CFS and ME Meeting Summary
• Apr 25-26, 2013, FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME)

Meeting Transcript

• Apr 25, 2013, "The Voice of the Patient" - Report on FDA public meeting for ME/CFS
• Apr 18, 2013, FDA 101 Webinar by David Banks. PhD
• Nov 15, 2012, Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change
• Sept 13, 2012, Teleconference between FDA and Patients/Patient Advocates

FDA response to Ampligen approval

• 2013, Response Letter Regarding Approval of Ampligen for ME/CFS
• 2013, Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS): Questions and Answers (Ampligen)

myalgic encephalomyelitis (M.E.) - A disease often marked by neurological symptoms, but fatigue is sometimes a symptom as well. Some diagnostic criteria distinguish it from chronic fatigue syndrome, while other diagnostic criteria consider it to be a synonym for chronic fatigue syndrome. A defining characteristic of ME is post-exertional malaise (PEM), or post-exertional neuroimmune exhaustion (PENE), which is a notable exacerbation of symptoms brought on by small exertions. PEM can last for days or weeks. Symptoms can include cognitive impairments, muscle pain (myalgia), trouble remaining upright (orthostatic intolerance), sleep abnormalities, and gastro-intestinal impairments, among others. An estimated 25% of those suffering from ME are housebound or bedbound. The World Health Organization (WHO) classifies ME as a neurological disease.