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| Center | Date | Time | Location |
|---|---|---|---|
| CDER | June 11, 2003 June 12, 2003 |
8:30 a.m. - 5:00
p.m. 8:00 a.m. - 5:00 p.m. |
Holiday Inn |
Agenda:
On June 11, 2003, the subcommittee will discuss the current epidemiology and
therapeutic interventions relevant to hyperbilirubinemia in the term and near-term
newborn.
On June 12, 2003, the subcommittee will begin with a closed session between 8 a.m. and 3 p.m. Following this, there will be an open subcommittee meeting from approximately 3:15 p.m. to 5 p.m., where the agency will report to the subcommittee on Adverse Event Reporting as mandated in Section 17 of the Best Pharmaceuticals for Children Act. The products to be discussed during this portion of the meeting include ZOLOFT (sertraline) Pfizer Inc., and DITROPAN (oxybutynin) Alza Corp., with an interim update to be provided on LIPITOR (atorvastatin) Pfizer Inc., and ZOCOR (simvastatin) Merck & Co. Inc.
Background material will become available no later than the day before the meeting and will be posted under the Dockets Management Branch site at http://www.fda.gov/ohrms/dockets/ac/03acdocs.htm. (Scroll down and select the appropriate advisory committee link.)
Closed Committee Deliberations:
On June 12, 2003, from 8:00 a.m. to 3:00 p.m., the meeting will be closed to
permit discussion and review of trade secret and/or confidential information
(5 U.S.C. 552b(c)(4)).
Procedure:
On Wednesday, June 11, 2003, from 8:00 a.m. to 5:00 p.m., the meeting is open
to the public. On Thursday, June 12, 2003, from 3:15 p.m. to 5:00 p.m., the
meeting is open to the public. 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 4, 2003. On June 11, 2003,
oral presentations from the public will be scheduled between approximately 3:00
p.m. and 4:00 p.m. On June 12, 2003, oral presentations from the public will
be scheduled between approximately 4:15 p.m. and 4:45 p.m. Time allotted for
each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before June 4, 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. 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 Thomas Perez at least 7 days in advance of the meeting.
Contact Person:
Thomas H. Perez, 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 by e-mail: perezt@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12530. Please call the Information Line for up-to-date
information on this meeting.