• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS)

 

FDA is planning a series of activities focused on drug development to treat the symptoms of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) in order to explore:

  • The burden of disease that impacts the quality of life for ME and CFS patients;
  • The quantitative outcome measures or endpoints that determine if disease symptoms improve with intervention; and
  • How drug efficacy should be clinically tested based on these endpoints or measurements.

Please send correspondence regarding ME and CFS to ME-CFS-Meeting@fda.hhs.gov.

Activities

Please Note: The list of activities will be updated as each activity is announced.

 Activity Date
Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis:
Developing Drug Products for Treatment; Availability
(Federal Register Notice)
March 11, 2014
Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment March 10, 2014
Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME) TeleconferenceOctober 16, 2013
FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME)April 25-26, 2013
CFS and ME Meeting SummaryApril 26, 2013
FDA 101 WebinarApril 18, 2013
Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for ChangeNovember 15, 2012
Teleconference between FDA and Patients/Patient AdvocatesSeptember 13, 2012