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Center | Date | Time | Location |
---|---|---|---|
CDER | February 16, 2005 February 17, 2005 February 18, 2005 |
8 a.m. - 6 p.m. 8 a.m. - 5 p.m. 8 a.m. - 5 p.m. |
Hilton Washington
DC North |
Agenda:
The committees will discuss the overall benefit to risk considerations (including
cardiovascular and gastrointestinal safety concerns) for COX-2 selective nonsteroidal
anti-inflammatory drugs and related agents.
Background material and meeting information will become available no later than one business day before each meeting day (Simply select the appropriate committee link).
Procedure:
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
Division of Dockets Management (see Addresses). Oral presentations from the
public will be scheduled between approximately 1 p.m. and 3 p.m. on February
17, 2005. Time allotted for each presentation may be limited. Those desiring
to make formal oral presentations should notify the contact person before February
4, 2005, 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.
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 Tony Slater at 301-827-7001, at least 7 days in advance of the
meeting.
Addresses:
Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments.
Select "2004N-0559-Overall Benefit to Risk Considerations for COX-2 Selective
Nonsteroidal Anti-inflammatory Drugs and Related Agents" and follow the
prompts to submit your statement. Written comments should be submitted to the
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments received by February 4,
2005, will be provided to the committee before the meeting.
Contact Person:
Kimberly Littleton Topper or Dornette Spell-LeSane, 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: 301-827-6801, e-mail: topperk@cder.fda.gov
or spelllesaned@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), codes 3014512532 or 3014512535. Please call the Information
Line for up-to-date information on this meeting.