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Center | Date | Time | Location |
---|---|---|---|
CDER | May 5, 2004 | 8 a.m. - 5 p.m. | Center for Drug
Evaluation and Research |
Agenda:
From 8 a.m. to 3 p.m., the committee will discuss medication errors relating
to the labeling and packaging of various drug products in low-density polyethylene
plastic vials.
From 3 p.m. to 5 p.m., the committee will receive a progress report on the new
drug application (NDA) 21-107, LOTRONEX (alosetron hydrochloride), GlaxoSmithKline,
Risk Management Program.
Background material and meeting information will become available no later than the day before the meeting (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
contact person by April 27, 2004. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 11:30 a.m. and between approximately
3 p.m. and 3:30 p.m. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact person
before April 27, 2004, 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 Shalini Jain at least 7 days in advance of the meeting.
Contact Person:
Shalini Jain, Center for Drug Evaluation and Research (HFD-21), 5600 Fishers
Lane (for express delivery, 5630 Fishers Lane, rm.1093) Rockville, MD 20857,
301-827-7001, e-mail: jains@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512535. Please call the Information Line
for up-to-date information on this meeting.
[ Full FR Notice ]