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Center | Date | Time | Location |
---|---|---|---|
CDER | June 9, 2004 | 8 a.m. - 5 p.m. | Center for Drug
Evaluation and Research |
Agenda:
The subcommittee will meet between 8 a.m. and 1:30 p.m., and the agency will
report to the committee 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 HYCAMTIN (topotecan), TEMODAR (temozolomide),
EFFEXOR (venlafaxine), MONOPRIL (fosinopril), ALLEGRA (fexofenadine), DURAGESIC
(fentanyl), CILOXAN (ciprofloxacin), and VIGAMOX (moxifloxacin).
Following this, from approximately 1:30 p.m. to 3:30 p.m., the agency will provide an update on neonatal withdrawal syndrome and congenital eye malformations reported in infants whose mothers used selective serotonin reuptake inhibitors (SSRIs) during pregnancy.
From approximately 3:30 p.m. to 4 p.m., the agency will provide an overview of the Pediatric Research Equity Act, which was signed into law on December 3, 2003.
From 4 p.m. to 4:30 p.m., there will be an overview of the Institute of Medicine report entitled "Ethical Conduct in Pediatric Clinical Trials."
Finally, from 4:30 p.m. to 4:45 p.m., the agency will provide an update on the subpart D, institutional review board referral process.
Background material and meeting information will become available no later than the 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 June 1, 2004. Oral presentations from the public will be scheduled
between approximately 11:15 a.m. and 11:45 a.m., for issues related to the section
17 adverse event reports. Also, oral presentations from the public will be scheduled
between approximately 3 p.m. and 3:30 p.m., for issues related to neonatal withdrawal
syndrome and congenital eye malformations seen in infants. Time allotted for
each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before June 1, 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 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 3014512530. Please call the Information Line
for up-to-date information on this meeting.
[ Full FR Notice ]