Drug Development for CFS and ME: Public Workshop
Dates: April 25, 2013 from 1:00 PM - 5:00 PM and April 26, 2013 from 8:30 AM - 5:00 PM
Summary: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is announcing a public workshop to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME). FDA has determined that CFS and ME are serious conditions for which there are no approved drug treatments. On April 25, 2013, as part of FDA’s Patient-Focused Drug Development initiative, patients will provide feedback on disease impact on quality of life and individual experience with current treatment regimens. On April 26, 2013, there will be discussions with academic and Government experts, patient advocates, patients, and clinicians on how to identify sound, quantitative outcome measures that can be used in clinical trials to determine whether disease symptoms improve with specific drug interventions.
PLEASE KEEP IN MIND THAT REGISTRATION IS ON A FIRST-COME, FIRST-SERVE BASIS.
Please see the following webpage for information on FDA activities related to ME and CFS: http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm
This website will also contain the Federal Register Notice link, webcast link, agenda, etc. once they become available.
NOTE FOR WEBCAST ATTENDEES: THE LINK FOR THE MEETING WEBCAST WILL BE POSTED ON THIS WEBPAGE APPROXIMATELY ONE WEEK PRIOR TO THE MEETING. http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm