This 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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.