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.
Please Note: The list of activities will be updated as each activity is announced.
|Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis:|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) Teleconference||October 16, 2013|
|FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME)||April 25-26, 2013|
|CFS and ME Meeting Summary||April 26, 2013|
|FDA 101 Webinar||April 18, 2013|
|Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change||November 15, 2012|
|Teleconference between FDA and Patients/Patient Advocates||September 13, 2012|
Follow-up Webinar Questions/Comments(PDF - 55KB) FDA Response Letter Regarding Approval of Ampligen for ME/CFS Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS): Questions and Answers How FDA Evaluates Regulated Products: Drugs
- IND Application Process
- Information for IND Submissions
- Guidance on Expedited Programs (PDF - 276KB)