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| Center | Date | Time | Location |
|---|---|---|---|
| CDER | June 25, 2003 June 26, 2003 |
8:30 a.m. - 5:00
p.m. 8:30 a.m. - 5:00 p.m. |
Marriott Washingtonian
Center |
Agenda:
On June 25, 2003, the committee will discuss new drug application (NDA) 21-597,
SEROSTIM (somatropin), Serono Inc., for the treatment of short bowel syndrome
in patients receiving specialized nutritional support. SEROSTIM therapy should
be used in conjunction with optimal management of short bowel syndrome.
On June 26, 2003, the committee will discuss NDA 21-525, PHOTOFRIN (porfirmer sodium), Axcan Scandipharm, Inc. Photodynamic therapy with PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett’s esophagus among patients who refuse esophagectomy and who are in overall good health.
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.)
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 16, 2003. Oral presentations from the public will be
scheduled between approximately 1:00 p.m. to 2:00 p.m. on both days. Time allotted
for each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before June 16, 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) 827-6758, or 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 12538. Please call the Information Line for up-to-date
information on this meeting.