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U.S. Food and Drug Administration
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==FDA activities on drug development for Myalgic Encephalomyelitis & Chronic Fatigue Syndrome== *Apr, 23, 2014 [http://www.fda.gov/Training/GuidanceWebinars/ucm392577.htm FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment] by Janet Maynard, MD, MP ::[https://collaboration.fda.gov/p3koai19ya2/?launcher=false&fcsContent=true&pbMode=normal Webinar] ::[http://www.fda.gov/downloads/Training/GuidanceWebinars/UCM394663.pdf Slides] ::[http://www.fda.gov/downloads/Drugs/NewsEvents/UCM399383.pdf Follow-up to the April 23, 2014 Webinar - Written Questions and Answers] *Mar 11, 2014, [https://www.gpo.gov/fdsys/pkg/FR-2014-03-11/pdf/2014-05189.pdf Federal Register Notice of Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment; Availability] *Mar 10, 2014, [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM388568.pdf Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment] (12 pages) *Oct 16, 2013, [http://www.fda.gov/Drugs/NewsEvents/ucm370166.htm Chronic Fatigue Syndrome and Myalgic Encephalomyelitis (CFS and ME) Stakeholder Teleconference] [http://www.fda.gov/downloads/drugs/newsevents/ucm371482.pdf Transcript of Teleconference] *Apr 26, 2013, [http://www.fda.gov/Drugs/NewsEvents/ucm386705.htm CFS and ME Meeting Summary] *Apr 25-26, 2013, [http://www.fda.gov/Drugs/NewsEvents/ucm369563.htm FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME)] ::[http://www.fda.gov/downloads/drugs/newsevents/ucm354951.pdf Meeting Transcript] *Apr 25, 2013, [http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdf "The Voice of the Patient" - Report on FDA public meeting for ME/CFS] *Apr 18, 2013, [https://collaboration.fda.gov/p64487010/?launcher=false&fcsContent=true&pbMode=normal FDA 101 Webinar by David Banks. PhD] *Nov 15, 2012, [http://www.fda.gov/Drugs/NewsEvents/ucm369564.htm Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change] *Sept 13, 2012, [http://www.fda.gov/Drugs/NewsEvents/ucm369565.htm Teleconference between FDA and Patients/Patient Advocates]
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