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
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Beginning Again: Living with the Ups and Downs of Life with Chronic Illness

Chronic Christmas: Surviving the Holidays with a Chronic Illness

Productivity Values That Get in the Way of Our Health

Happiness, Gratitude and Appreciation

The “Starvation” Disease? Metabolomics Meets Chronic Fatigue Syndrome Down Under

Vital Molecule Increases Cellular Energy and Improves Cognitive Function

The IACFS/ME 2016 Conference Overviews #1: Energy and Exercise To the Fore

Is Chronic Fatigue Syndrome An Inflammatory Disease? The 2016 IACFS/ME Conference Overviews Pt II

Psychotherapy for ME/CFS Does Not Help Fatigue (much)

Medscape Rocks the IACFS/ME Conference

Print Page
Email Article

The FDA Announces Public Workshop for CFS and ME

  [ 11 votes ]   [ Discuss This Article ] • March 21, 2013


~For more information, please go HERE

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is announcing a public workshop to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME). FDA has determined that CFS and ME are serious conditions for which there are no approved drug treatments. On April 25, 2013, as part of FDA's Patient-Focused Drug Development initiative, patients will provide feedback on disease impact on quality of life and individual experience with current treatment regimens. On April 26, 2013, there will be discussions with academic and Government experts, patient advocates, patients, and clinicians on how to identify sound, quantitative outcome measures that can be used in clinical trials to determine whether disease symptoms improve with specific drug interventions.

Date and Time: The public workshop will be held on April 25, 2013, from 1 p.m. to 5 p.m., and on April 26, 2013, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814, 301-897-9400, Fax: 301-897-0192.

Contact Persons:

Mary Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3519,;

Randi Clark, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4287,; or

Sara Eggers, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4904,

Registration and Requests to Participate in Panel Discussions: If you wish to attend the public workshop or participate in a panel discussion, you must register by submitting an electronic or written request by 5 p.m. on April 8, 2013. Submit electronic requests HERE. Submit written requests to Mary Gross, Randi Clark, or Sara Eggers (see Contact Persons). You must provide your name and business, organization, or personal affiliation as applies (e.g., industry, government, patient). Patients who are interested in presenting comments as part of the initial panel discussions may indicate which topic(s) they wish to address (see section II of this document).

The public workshop is free and seating will be on a first-come, first-served basis. We recommend that you register early because seating is limited. FDA may limit both the number of participants from individual organizations and the total number of attendees, based on space limitations. Registrants will receive confirmation once they have been accepted to attend the meeting. For those who cannot attend in person, a live Webcast of the meeting will be located at ME/CFS meeting. For information about joining the meeting via Webcast, please go HERE

FDA will post an agenda of the public workshop and other background material 5 days before the workshop at Drugs/News/Events

You may submit questions about the public workshop to prior to the April 25 and 26 workshop dates.

If you need special accommodations because of a disability, contact Mary Gross, Randi Clark, or Sara Eggers (see Contact Persons) at least 7 days in advance.

Comments: Submit either electronic or written comments by April 8, 2013, to receive consideration. Submit electronic comments to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at Electronic or written comments will be accepted after the meeting until August 2, 2013.

FDA will also hold an open public comment period on April 25 to give the public an opportunity to comment on topics that may not have been addressed in the discussion of topics 1 and 2 (see section II of this document). Workshop participants should register to participate in the open public comment period by April 8, 2013, and will be asked to provide a brief summary of their comments.

Post a Comment

Featured Products From the ProHealth Store
Energy NADH™ 12.5mg MitoQ® Hydroxocobalamin Extreme™

Article Comments

Be the first to comment on this article!

Post a Comment

Natural Pain Relief Supplements

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
MitoQ® MitoQ®
Powerful Antioxidant Support to Mitochondria
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth

Natural Remedies

Herbal Rescue for High Blood Sugar Herbal Rescue for High Blood Sugar
"It's Not Easy Being Green" - But It Is Healthy
Breaking Through the Mental Fog Breaking Through the Mental Fog
The Remarkable Benefits of Reishi Medicinal Mushrooms The Remarkable Benefits of Reishi Medicinal Mushrooms
Thyroid Health and Fibromyalgia Thyroid Health and Fibromyalgia

ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
Credit Card Processing
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map