U.S. Food and Drug Administration: Difference between revisions

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The [http://www.fda.gov/ 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]].
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]]==
==FDA activities on drug development for Myalgic Encephalomyelitis & Chronic Fatigue Syndrome==
*23 Apr, 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
*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]
::[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/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]
::[http://www.fda.gov/downloads/Drugs/NewsEvents/UCM399383.pdf Follow-up to the April 23, 2014 Webinar - Written Questions and Answers]
*11 Mar 2014, [https://www.gpo.gov/fdsys/pkg/FR-2014-03-11/pdf/2014-05189.pdf Federal Register Notice of Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment; Availability]
*Mar 11, 2014, [https://www.gpo.gov/fdsys/pkg/FR-2014-03-11/pdf/2014-05189.pdf Federal Register Notice of Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment; Availability]
*10 Mar 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)
*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)
*16 Oct 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]  
*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]  
*26 Apr 2013, [http://www.fda.gov/Drugs/NewsEvents/ucm386705.htm CFS and ME Meeting Summary]
*Apr 26, 2013, [http://www.fda.gov/Drugs/NewsEvents/ucm386705.htm CFS and ME Meeting Summary]
*25-26 Apr 2013, [http://www.fda.gov/Drugs/NewsEvents/ucm369563.htm FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME)]  
*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]  
::[http://www.fda.gov/downloads/drugs/newsevents/ucm354951.pdf Meeting Transcript]  
*25 Apr 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 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]  
*18 Apr 2013, [https://collaboration.fda.gov/p64487010/?launcher=false&fcsContent=true&pbMode=normal FDA 101 Webinar by David Banks. PhD]
*Apr 18, 2013, [https://collaboration.fda.gov/p64487010/?launcher=false&fcsContent=true&pbMode=normal FDA 101 Webinar by David Banks. PhD]
*15 Nov 2012, [http://www.fda.gov/Drugs/NewsEvents/ucm369564.htm Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change]
*Nov 15, 2012, [http://www.fda.gov/Drugs/NewsEvents/ucm369564.htm Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change]
*13 Sept 2012, [http://www.fda.gov/Drugs/NewsEvents/ucm369565.htm Teleconference between FDA and Patients/Patient Advocates]
*Sept 13, 2012, [http://www.fda.gov/Drugs/NewsEvents/ucm369565.htm Teleconference between FDA and Patients/Patient Advocates]


==FDA response to [[Ampligen]] approval==
==FDA response to [[Ampligen]] approval==

Revision as of 15:39, November 18, 2019

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[edit | edit source]

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

FDA response to Ampligen approval[edit | edit source]

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.

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