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FDA Webinar: Draft Guidance for Industry-

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment

On Wednesday, April 23, 2014, from 1:00 p.m. – 2:00 p.m. EDT, FDA will present a webinar on the draft guidance for industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.

Draft Guidance for Industry 

Federal Register Notice of Availability

SUMMARY: This draft guidance is intended to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). It focuses on specific drug development and trial design issues that are unique to the study of CFS/ME, and on FDA’s current thinking on how effective treatments can be developed for CFS/ME. The points made in this draft guidance may not be applicable to all drug products. 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).

SPEAKER:

Janet Maynard, M.D., Medical Officer

Division of Pulmonary, Allergy, and Rheumatology Products

Office of New Drugs. Center for Drug Evaluation and Research. FDA

Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.

Webinar access link: https://collaboration.fda.gov/gfiwebinar

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided.

Questions/Comments can be submitted live via a Q/A chat window.

Please note: There is a user capacity limit for this webinar. For those who cannot enter the webinar, please know that it will be recorded and a link will be posted to this page within one business day.

For questions concerning the webinar, please contact Marsha Holloman (301-796-0731). 

Information on fda.gov: FDA Webinar April 23 

FDA’s Guidance Webinar Series: http://www.fda.gov/Training/GuidanceWebinars/default.htm