FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment - April 23, 2014
The Office of Medical Policy (OMP) in CDER presented another in a series of webinars on 60-day draft guidances for industry on Wednesday, April 23, 2014. The topic was “CHRONIC FATIGUE SYNDROME”.
PUBLICATION DATE: 03/11/2014
COMMENTS DATE: 05/12/2014
DOCKET NUMBER: FDA–2014–D–0264
Janet Maynard, MD and others
Division of Pulmonary, Allergy, and Rheumatology Products
Office of New Drugs
SUMMARY: This draft guidance is intended to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). This guidance focuses on specific drug development and trial design issues that are unique to the study of CFS/ME and on the FDA’s current thinking on how effective treatments can be developed for CFS/ME. The points discussed in this guidance may not be applicable to all drug products. The FDA encourages sponsors to design clinical programs that fit their particular needs and to discuss their planned approach with the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP).