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Center | Date | Time | Location |
---|---|---|---|
CDER | December 2, 2004 | 8 a.m. - 5:30 p.m. | Hilton |
Agenda:
The committee will discuss new drug application (NDA) 21–769, Testosterone
Transdermal System (proposed tradename, Intrinsa) by Procter and Gamble, indicated
for the treatment of hypoactive sexual desire disorder in surgically menopausal
women receiving concomitant estrogen therapy.
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 November 17, 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 November 17, 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 Teresa Watkins at least 7 days in advance of the meeting.
Contact Person:
Teresa Watkins, 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: watkinst@cder.fda.gov
or FDA Advisory Committee Information Line, 1-800-741 8138 (301-443-0572 in
the Washington, DC area), code 3014512537. Please call the Information Line
for up-to-date information on this meeting.