Anonymous asked in Business & FinanceOther - Business & Finance · 8 years ago

Any info on Ampligen's FDA regulatory review process?

1 Answer

  • Anonymous
    8 years ago
    Favorite Answer

    Instructions for FDA Meeting Dec. 20, 2012:

    December 20, 2012: Arthritis Advisory Committee Meeting Announcement


    December 20, 2012

    8:00 a.m. to 5:00 p.m.

    FDA White Oak Campus

    Building 31

    Great Room (Rm. 1503)

    White Oak Conference Center

    10903 New Hampshire Avenue Silver Spring, Maryland

    AgendaThe committee will discuss new drug application (NDA) 22151, rintatolimod injection (proposed trade name AMPLIGEN) submitted by Hemispherx Biopharma, Inc. for the treatment of patients with chronic fatigue syndrome.Meeting MaterialsFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.Background Material◦2012 Meeting Materials, Arthritis Advisory Committee

    Public Participation InformationInterested persons may present data, information, or views, orally or in writing, on issues pending before the committee.◦Written submissions may be made to the contact person on or before December 6, 2012.

    ◦Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:30 p.m. on December 20, 2012. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 28, 2012.

    Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 29, 2012.Webcast InformationCDER plans to provide a free of charge, live webcast of the December 20, 2012, meeting of the Arthritis Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2012 Meeting Materials, Arthritis Advisory Committee

    CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.Contact Information◦Yvette Waples, PharmD

    Center for Drug Evaluation and Research

    Food and Drug Administration

    10903 New Hampshire Avenue


    Silver Spring, MD 20993-0002

    Phone: 301-796-9001

    Fax: 301-847-8533


    ◦FDA Advisory Committee Information Line

    1-800-741-8138 (301-443-0572 in the Washington DC area)

    Please call the Information Line for up-to-date information on this meeting

    A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

    Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Yvette Waples at (301) 796-9001 at least 7 days in advance of the meeting.

    Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

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