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Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee

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Center Date Time Location
CDER October 23, 2008
8:00 a.m. - 5:00 p.m.
Hilton Washington DC
Silver Spring, The Ballrooms,
8727 Colesville Rd., Silver Spring, MD

Agenda

IThe Committee will discuss the clinical development of radionuclide imaging products for the detection of amyloid to assist in the diagnosis of Alzheimer’s Disease.

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 is available at http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link.

Meeting Materials

Links to meeting materials will be added as they become available.

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 October 8, 2008.
  • Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m., October 8. 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 September 30, 2008.

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 October 1, 2008.

Contact Information

  • Diem-Kieu Ngo
    Center for Drug Evaluation and Research (HFD–21)
    Food and Drug Administration
    5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093)
    Rockville, MD 20857
    301–827– 7001
    FAX: 301–827–6776
    e-mail: Diem.Ngo@fda.hhs.gov, or
    FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572) in the Washington, DC area), code 3014512543
    Please call the Information Line for up-to-date information on this meeting.

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Date created: September 5, 2008