FDA is hosting a webinar about the draft guidance document “Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment”.
Note: the webinar will be close-captioned and there questions/comments can be submitted in real-time using a chat window. (It is safe to assume that personal information should not be submitted as this would then be available for all to see onscreen.)
Public comment on the draft guidance should also be submitted to the docket DOCKET NUMBER: FDA–2014–D–0264 http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0264 – as it then becomes part of the public record.
“FDA’s Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders.” (http://www.fda.gov/Training/GuidanceWebinars/default.htm)
“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 presents another in a series of webinars on 60-day guidances for industry on Wednesday, April 23, 2014 from 1PM - 2PM EDT. The topic is “CHRONIC FATIGUE SYNDROME”.
PUBLICATION DATE: 03/11/2014
COMMENTS [DUE] DATE: 05/12/2014
DOCKET NUMBER: FDA–2014–D–0264 http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0264
Janet Maynard, MD and others
Division of Pulmonary, Allergy, and Rheumatology Products
Office of New Drugs
SUMMARY: 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 (DPARP).
For questions concerning the webinar, please contact Marsha Holloman (301-796-0731)
Webinar information on FDA’s Web site: http://www.fda.gov/Training/GuidanceWebinars/default.htm
Guidance Webinar Online-Access Instructions:
To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.
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.
Access link: https://collaboration.fda.gov/gfiwebinar”