On April 25 and 25, 2013, the Center for Drug Evaluation and Research held 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). 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 provided feedback on disease impact on quality of life and individual experience with current treatment regimens. On April 26, 2013, academic and government experts, patient advocates, patients, and clinicians discussed how to identify sound, quantitative outcome measures that can be used in clinical trials to determine whether disease symptoms improve with specific drug interventions.
On October 16 from 1:30 PM – 3:00 PM EST, FDA will hold a teleconference that is open to the public. FDA will provide introductory and background remarks then the teleconference will be open for public comment on the following three topics:
- Feedback from the CFS and ME public workshop.
- Current projects related to drug development in CFS and ME.
- Potential methods to catalyze CFS and ME drug development.