~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.
Mary Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3519, Mary.Gross@fda.hhs.gov;
Randi Clark, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4287, Randi.Clark@fda.hhs.gov; 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, Sara.Eggers@fda.hhs.gov.
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 ME-CFS-Meeting@fda.hhs.gov 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 www.regulations.gov. 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 http://www.regulations.gov. 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.