ProHealth me-cfs Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|

Trending News

The MTHFR Mutation: Important for CFS-ME? Important for everything?

Happiness, Gratitude and Appreciation

New clinical research program to combat chronic pain and chronic fatigue syndrome

It’s Still a Wonderful Life

Survey Data on Name Change for ME/CFS Analyzed for Publication

Lack of Knowledgeable Healthcare Access for Patients with Neuro-endocrine-immune Diseases

Assessment of activity limitations and participation restrictions with persons with chronic fatigue ...

Help the National ME/FM Action Network win $5000!

Shake That *^#&! ing Stigma – The “Shake the CFS Stigma Challenge” Begins

Now Is the Time for a National PR Campaign for ME/CFS!

 
Print Page
Email Article

FDA Announces Public Meeting for Fibromyalgia – Invites Comments from Patients

  [ 24 votes ]   [ Discuss This Article ]
www.ProHealth.com • October 10, 2013


FDA Announces Public Meeting for Fibromyalgia – Invites Comments from Patients

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for fibromyalgia. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow the FDA to obtain patients' perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia.

The public meeting will be held on December 10, 2013, from 1 p.m. to 5 p.m. In Silver Spring, Maryland. Registration to attend the meeting must be received by November 27, 2013. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis.

If you are not able to attend the meeting in person, you can also register to view the meeting via webcast.  For more information about location and to register to attend either in person or by webcast, go to https://patientfocusedfibromyalgia.eventbrite.com/

Request for Patient Input

As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on symptoms of fibromyalgia that matter most to patients and on current approaches to treating fibromyalgia. Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain and tenderness in multiple tender points and may be accompanied by fatigue, sleep disturbances, irritable bowel syndrome, headache, and mood disorders. While there is currently no definitive cure, treatments for fibromyalgia include medications and lifestyle changes with emphasis on minimizing symptoms and improving general health and daily function. FDA is interested in obtaining a better understanding of fibromyalgia patients' perspectives on the severity of the disease and the available therapies used to treat fibromyalgia and its symptoms.

The questions that will be asked of patients and patient stakeholders at the meeting are listed below, organized by topic. For each topic, a brief patient panel discussion will begin the dialogue, followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through written comments that patients can submit electronically or by mail.  Comments must be submitted by February 10, 2014.  Information on how to submit comments will follow the topics. 

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients

(1) Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most significant impact on your life? (Examples may include chronic pain, fatigue, difficulty concentrating, sleep disorders, etc.)

(2) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, driving, household chores, etc.)

(a) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?

(3) How have your condition and its symptoms changed over time?

(a) Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse?

(4) What worries you most about your condition?

Topic 2: Patients' Perspectives on Current Approaches to Treating Fibromyalgia

(1) What are you currently doing to help treat your condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as exercise or acupuncture)

(a) What specific symptoms do your treatments address?

(b) How has your treatment regimen changed over time, and why?

(2) How well does your current treatment regimen treat the most significant symptoms of your disease?

(a) How well do these treatments improve your ability to do specific activities that are important to you in your daily life?

(b) How well have these treatments worked for you as your condition has changed over time?

(3) What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital for treatment, restrictions on driving, etc.)

(4) What specific things would you look for in an ideal treatment for your condition?

To submit comments electronically:  Go to http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4219 and click the “Comment Now” button in the top right corner.

Or mail comments to:  Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket number FDA_FRDOC_0001-4219

For additional information, visit http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4219



Please Discuss This Article:   Post a Comment 



[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Save on Nutritional Supplement Orders

Featured Products

Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
MitoQ® MitoQ®
Powerful Antioxidant Support to Mitochondria
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth

Natural Remedies

Protect Against Sun-Induced Skin Aging From The Inside Out Protect Against Sun-Induced Skin Aging From The Inside Out
The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol
Fatigue & Fibro Fog: Could You Have a B-12 Deficiency? Fatigue & Fibro Fog: Could You Have a B-12 Deficiency?
Shoo Pain, Don't Bother Me - Top 10 Nutrients to Take Back Your Life Shoo Pain, Don't Bother Me - Top 10 Nutrients to Take Back Your Life
VIDEO: Healthy Eating and Fibromyalgia VIDEO: Healthy Eating and Fibromyalgia

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS Diagnosis
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE  |  PRIVACY
CONTACT US
LIBRARY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing