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Meeting of the Pediatric Advisory Committee

Agenda

On November 18, 2008, the Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports for BETOPTIC S (betaxolol), ALDARA (imiquimod), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), SANDOSTATIN (octreotide), ZYPREXA (olanzapine), RISPERDAL (risperidone), LAMISIL (terbinafine), TIMOLOL GFS (timolol), and AMBIEN (zolpidem). The committee will be provided a written followup report on ZYVOX (linezolid), as requested by the committee at the November 16, 2006, Pediatric Advisory Committee meeting. The committee will also be updated on other activities, including the June 9 and 10, 2008, Pediatric Ethics Subcommittee meeting.

Meeting Materials

Draft Agenda
Meeting Roster
Briefing Information
Slides

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 27, 2008.
• Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. on November 18, 2008.

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 October 17, 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 20, 2008.

Contact Information

• Carlos Pena
  Office of Commisioner
  Food and Drug Administration
  5600 Fishers Lane, HF-33
  Rockville, MD  20857
  Phone: 301-827-6687 FAX: 301-827-3042
  e-mail: Carlos.Pena@fda.hhs.gov
• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington, DC, area)
  code 8732310001
  Please call the Information Line for up-to-date information on this 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 Carlos Pen˜ a at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings.

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

Advisory Committee Calendar
Advisory Committee Home Page

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