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| Center | Date | Time | Location |
|---|---|---|---|
| CDER | June 12, 2003 | 8:00 a.m. - 5:00 p.m. | Holiday Inn |
Note: Interested persons and organizations may submit written or electronic comments until August 1, 2003, to the Dockets Management Branch (see Addresses below).
Agenda:
The committee will consider the safety and efficacy of ipecac syrup, indicated
for emergency use to cause vomiting in poisoning, for continued over-the-counter
(OTC) status under 21 CFR 201.308. The primary areas of consideration are: (1)
The status of the role of ipecac syrup in gastrointestinal decontamination;
(2) whether the literature clearly defines the risk/benefit ratio of ipecac
syrup; (3) the role of ipecac syrup in poison treatment for populations with
limited access to emergency medical treatment; (4) if there is significant abuse
of ipecac syrup; and (5) alternative therapies to ipecac syrup.
Background material will become available no later than the day before the meeting and will be posted under the Nonprescription Drugs Advisory Committee (NDAC) docket site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2003 and scroll down to NDAC meetings.)
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 June 5, 2003. Oral presentations from the public will be scheduled
between approximately 1:00 p.m. and 2:00 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before June 5, 2003, 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. However, until August 1, 2003, other
submissions containing the docket number 03N-0143 and information relevant to
the agenda of this meeting may be submitted for consideration to Dockets Management
Branch (see Addresses).
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 Karen Templeton-Somers at least 7 days in advance of the meeting.
Contact Person:
Karen M. Templeton-Sommers, 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, or e-mail: SomersK@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12541. Please call the Information Line for up-to-date
information on this meeting.
Addresses:
Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments.
Select "03N-0143-Continued over-the-counter status of ipecac syrup"
and follow the prompts to submit your statement. Written comments should be
submitted to Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.