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Center | Date | Time | Location |
---|---|---|---|
CDER | September 8, 2004 | 8 a.m. - 5 p.m. | Holiday Inn |
Agenda:
On September 8, 2004, the committee will discuss the FDA draft guidance document
entitled ‘‘Guidance for the Clinical Evaluation of Weight-Control
Drugs,’’ issued September 24, 1996 (see 69 FR 3588, January 26,
2004, including solicitation for comments [Docket No. 2003D–0570], see
also the FDA Internet at http://www.fda.gov/cder/guidance/index.htm
under the heading ‘‘Clinical/Medical (Draft)’’).
Background material and meeting information will become available no later than one business 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 August 31, 2004. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 12 noon. Time allotted for each
presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before August 31, 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 Dornette Spell-LeSane, at least 7 days in advance of the meeting.
Contact Person:
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: 301–827–6776, e-mail: dornette.spelllesane@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512536. Please call the Information Line
for up-to-date information on this meeting.
[ Full FR Notice ]