Archive for February, 2014

Summary of April 26, 2013 FDA meeting (day 2)

Recently FDA released a summary (http://www.fda.gov/Drugs/NewsEvents/ucm386705.htm) of the April 26, 2013 FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME). You may recall that this was the second day of a 1.5 day meeting and on this day, there were discussions about identifying quantitative outcome measures and determining which treatments produce improvements.

Remember that FDA is currently producing a guidance document for CFS and ME drugs that will provide advice for pharmaceutical companies and industry to expedite research for treatments. Our input will be needed on this. Note – typically when a draft guidance is released there is a 60 day comment period.

Additional information about the meeting and links to transcripts etc. can be found here: http://www.fda.gov/Drugs/NewsEvents/ucm369563.htm

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