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FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
| FDA | Date | Time | Location |
|---|---|---|---|
| Office of the Commissioner | February 14, 2005 February 15, 2005 |
2 p.m. - 6 p.m. 8 a.m. - 4:30 p.m. |
Center for Drug
Evaluation and Research |
Agenda:
On Monday, February 14, 2005, the committee will discuss an agency report on
Adverse Event Reporting, as mandated in Section 17 of the Best Pharmaceuticals
for Children Act (BPCA), for LOTENSIN (benazepril), BREVIBLOC (esmolol), MALARONE
(atovaquone/proguanil), VIRACEPT (nelfinavir), XENICAL (orlistat), and GLUCOVANCE
(glyburide/metformin). The committee will also be asked to advise the agency
on how to improve the process and content of the adverse event reviews and reporting
as mandated by BPCA.
On Tuesday, February 15, 2005, the committee will discuss risk evaluation, labeling, risk communication, and dissemination of information on potential cancer risk among pediatric patients treated for atopic dermatitis with topical dermatological immunosuppressants.
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
contact person by February 7, 2005. Oral presentations from the public will
be scheduled on Monday, February 14, 2005, between approximately 4 p.m. and
4:30 p.m. and on Tuesday, February 15, 2005, between approximately 12 noon and
12:30 p.m. Time allotted for each presentation may be limited. Those desiring
to make formal oral presentations should notify the contact person before February
7, 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 Jan Johannessen at least 7 days in advance of the meeting.
Contact Person:
Jan N. Johannessen, Office of Science and Health Coordination
of the Office of the Commissioner (HF–33), Food and Drug Administration,
5600 Fishers Lane, (for express delivery, Rm. 14C–06) Rockville, MD 20857,
301–827–6687, e-mail: jjohannessen@fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 8732310001. Please call the Information Line
for up-to-date information on this meeting.