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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The Office of Medical Policy (OMP) in CDER presents another in a series of webinars on 60-day draft guidances for industry on Wednesday, April 23, 2014 from 1PM - 2PM EDT. The topic is “CHRONIC FATIGUE SYNDROME”.
SUMMARY: This draft guidance is intended to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).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 fir their particular needs and to discuss their planned approach with the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP).
For more information, please visit: Chronic Fatigue Syndrome
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