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FDA Reschedules Fibromyalgia Patient-Focused Drug Development Meeting: Invites Patient Input

  [ 5 votes ]   [ 3 Comments ]
www.ProHealth.com • February 3, 2014


FDA Reschedules Fibromyalgia Patient-Focused Drug Development Meeting: Invites Patient Input
Last October the FDA announced a public meeting on Patient-Focused Drug Development for fibromyalgia and invited input from patients.  The meeting, originally set for December 10, 2013, has been rescheduled for March 26, 2014.  They are still seeking input from FM patients.  If you would like to attend the meeting, you can register to attend either in person or via Webcast.  

Following is the FDA notice giving details of the meeting and links to register or submit comments:

On March 26, 2014, FDA is conducting a public meeting on Patient-Focused Drug Development for fibromyalgia. FDA is interested in obtaining patient input on the impact of fibromyalgia on daily life and patients’ views on currently available therapies to treat the condition. This is a rescheduling of the original December 10, 2013 meeting.

This website will be updated as additional meeting information becomes available.

 Date:  March 26, 20114
 Time:  1:00 p.m. to 5:00 p.m. EDT
 Location:  FDA White Oak Campus
 10903 New Hampshire Ave.
 Building 31, Room 1503 B and C (Great Room)
 Silver Spring, MD 20993
 (Information about arrival to FDA’s White Oak campus)
 Registration:  To register for this meeting, visit: https://marchfibromyalgia.eventbrite.com.
 Registration will close on March 20, 2014.











Submitting comments to the docket: In addition to providing input at the public meeting, patient stakeholders can  provide their perspectives on the discussion questions through the public docket. The docket closes on May 26, 2014. To submit your comments, visit  http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1041-0001.

Alternatively, you can fax or mail your comments. Fax comments  to the Division of Dockets Management at 301-827-6870, or mail comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should include the docket number FDA-2013-N-1041.

Source:Public Meeting on Fibromyalgia Patient-Focused Drug Development.” FDA Notice, January 23, 2014.



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Article Comments Post a Comment

Fibromyalgia
Posted by: Kazz1966
Feb 12, 2014
I hav been diagnosed fibromyalgia nrly 2yrs now but I was suffering for 8yrs before dionosis. May say it has been the worse yrs of my life I was almost convinced the pain was all in my head a few times until I read a comment on a book I found it said no pain is in ur head a pains a pain. I felt happy & relieved when I was diagnosed why u might ask well in my eyes it was finally recognised that something was really wrong with me. I am in constant pain all over my body every single day sum days worse than others my bad days I can't even get out my bed. Almost every day I'm in my night wear and if on a good day I manage to go shopping I treat myself to new pajamas as there's no point buying clothes as my social life is non existent. I am 47 and feel 97. I hav 2 children and my daughter has now been diagnosed with fibromyalgia so I also carry the guilt that I may hav passed it on to her. I've felt like giving up a lot of times but it's my children that prevent me from doing something silly. I would rather give birth 20 days in a row than live with fibro.
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fibro
Posted by: tootired!
Feb 16, 2014
I'm a 67 year old woman who has suffered with fibromyalgia for 20+ years. I'm a very active person so dealing with the all- over pain has been taking me down. Still I keep on and it used to be when I couldn't move any more I'd take a prescription pain medication. I tried Lyrica for 6 weeks last fall and ended up 10 lbs. heavier which I certainly did NOT need!! I stopped the Lyrica and went back to just taking something when the pain was too much. Now my dr. has me on a 4 dose a day script for pain. I'm not into taking pills, but I'm never going to just sit down and die. So what to do?? I've checked into gluten intolerance and have been avoiding gluten for about 3 weeks. I'm having some good mornings now and the brain fog seems to be lifting. Maybe we have something here!!
Reply Reply

Fibromyalgia Meds
Posted by: BarbaraP
Apr 21, 2014
What I can't understand is that there are doctors who know how to treat fibromyalgia. There can also be many underlying conditions that need to be treated also. Look up Fibromyalgia and Fatigue Centers. They have clinics all over the country and actually understand what FM is and how to treat it. Western medicine CANNOT do anything but put Bandaids on it. The crux of the treatment is an IV infusion and after about 9 infusions in as many weeks a whole new world opens up--one I can barely remember. Unfortunately the clinic in Raleigh, NC is no longer in existence and the closest clinic is in Atlanta and I can't easily get there so I haven't been able to get maintenance treatments and have gotten sick again. I don't intend to argue with anyone about this. I know what I've experienced and I know we don't need any more Bandaids. Western medicine needs to wake up and admit they can't treat FM and CFS and let the doctors who do know be allowed to do it without fear of repercussions.
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