This notice was posted to the FDA’s website and circulated to the Department of Health and Human Services CFS Advisory Committee’s public listserv. Inquiries should be directed to FDA at ME-CFS-Meeting@fda.hhs.gov.
FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME) – Update
The public workshop will be held on the afternoon of April 25 and all day, April 26, at the Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814.
Beginning at 1:00 pm on April 25, FDA will gather patients’ perspectives on CFS and ME through a facilitated group discussion focusing on two main topics: (1) disease symptoms and daily impacts that matter most to patients; and (2) patients’ perspectives on current approaches to treating CFS and ME. The second day will include a scientific discussion with patients, clinicians, researchers and government experts focusing on how to identify quantitative outcome measures to determine if disease symptoms improve with specific drug interventions.
Additional information will be posted soon, including the Federal Register Notice that will describe the meeting format and provide details about how to register to attend the meeting.