FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing D

[Denise]

This was sent out for the FDA by the CFSAC ListServ
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”.



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

FR NOTICE

PUBLICATION DATE: 03/11/2014

COMMENTS DATE: 05/12/2014 [Deadline for submission of comments]

DOCKET NUMBER: FDA–2014–D–0264


SPEAKERS:

Janet Maynard, MD and others

Medical Officer

Division of Pulmonary, Allergy, and Rheumatology Products

Office of New Drugs

CDER/FDA


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 fir 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 contactMarsha Holloman (301-796-0731).

Webinar information on FDA’s Web site:http://www.fda.gov/Training/GuidanceWebinars/ucm369019.htm

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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

http://www.fda.gov/Training/GuidanceWebinars/ucm392577.htm

 

[A.B.]

This sounds surprisingly reasonable and appropriate, even though I would have preferred to see (even) more emphasis on objective outcomes, ie. PEM.

 

[Denise]

This sounds surprisingly reasonable and appropriate, even though I would have preferred to see (even) more emphasis on objective outcomes, ie. PEM.

I agree that objective outcome measures should be more clearly specified.

Please share your concerns with FDA - you can do so during the webinar but in addition please submit concerns to the docket as doing so makes it a part of the public record.

 

[Denise]

REMINDER for Wednesday 23 April 2014 1pm eastern time (US)

This webinar is about the Draft Guidance to Industry on Drug Development for ME/CFS (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM388568.pdf)

The webinar will have some Q&A time – so make submit your questions.



“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.”

http://www.fda.gov/Training/GuidanceWebinars/ucm392577.htm



In your public comment on the Draft Guidance (due 12 May 2014), consider including the positives in the guidance as well as concerns you may have.

Submit your written comments to the docket (Docket No. FDA-2014-D-0264 ) http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2014-D-0264;fp=true;ns=true