FDA Releases New Draft Guidance for Industry “CFS/ME: Developing Drug Products for Treatment”



UPDATE: April 10, 2014

FDA is pleased to announce an upcoming webinar regarding the Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.

The webinar will be held on Wednesday, April 23, 2014 from 1pm-2pm. 

Additional information regarding the webinar can be found HERE


On March 11, 2014, FDA released a draft guidance for industry entitled “Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.”  The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of CFS/ME.

The guidance has been posted online and can be found HERE


The Solve ME/CFS Initiative is pleased that FDA is doing what is required to advance safe and effective drug development for ME/CFS. At theApril 2013 FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME), Theresa Michele, M.D. of the Office of Drug Development at the FDA, noted that guidance for industry was an important next step for the FDA. (Access the webinar recording and transcripts HERE.) In our initial review of the draft, it appears the FDA drafted this drug development guidance based on input from patients regarding the most significant symptoms and negative impacts of ME/CFS on their lives.  This input from patients is critically important.

FDA will be accepting feedback on this draft guidance prior to finalizing it. Interested persons may submit their electronic or written comments regarding this document.  The Federal Register notice regarding this draft guidance and additional details regarding submission of comments is available online HERE:


The Solve ME/CFS Initiative is reviewing the draft guidance document more thoroughly with members of its Research Advisory Council in order to provide the most informed comments to the docket prior to the deadline of May 12, 2014.

We will keep you informed and share our more thorough review once completed.


Tags: , , March 13, 2014