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.

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

 * 23 Apr, 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


 * 11 Mar 2014, Federal Register Notice of Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment; Availability
 * 10 Mar 2014, Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment (12 pages)
 * 16 Oct 2013, Chronic Fatigue Syndrome and Myalgic Encephalomyelitis (CFS and ME) Stakeholder Teleconference Transcript of Teleconference
 * 26 Apr 2013, CFS and ME Meeting Summary
 * 25-26 Apr 2013, FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME)
 * 18 Apr 2013, FDA 101 Webinar by David Banks. PhD
 * 15 Nov 2012, Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change
 * 13 Sept 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)