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Titan Pharmaceuticals Inc. Message Board

  • stalyon52 stalyon52 Mar 15, 2013 7:56 AM Flag

    March 21, 2013 Meeting

    March 21, 2013: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement
    Center Date Time Location
    CDER March 21, 2013 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
    Building 31
    The Great Room (Rm. 1503)
    White Oak Conference Center
    10903 New Hampshire Avenue
    Silver Spring, Maryland
    Agenda
    On March 21, 2013, the committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Titan Pharmaceuticals, Inc., and its safety and efficacy for the proposed indication of maintenance treatment of opioid dependence.
    Meeting Materials
    FDA 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:
    2013 Meeting Materials, Psychopharmacologic Drugs Advisory Committee1
    Public Participation Information
    Interested 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 March 14, 2013.
    Oral presentations from the public will be scheduled between approximately 1:45 p.m. to 2:45 p.m. on March 21, 2013. 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 March 6, 2013.
    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

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