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horizonal rule

Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee

Center Date Time Location
CDER February 03, 2004
February 04, 2004
9 a.m. - 4:45 p.m.
8 a.m. - 12 noon

CDER Advisory Committee Conference Room
Rm. 1066
5630
Fishers Lane
Rockville, MD

Draft Agenda | Draft Questions | Briefing Information |
February 3, Slides
| February 3, Transcript | February 4, Transcript | February 3-4 Summary Minutes

Agenda:
On February 3, 2004, the subcommittee will meet between 9 a.m. and 10:15 a.m., and the agency will report to the subcommittee on Adverse Event Reporting as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA). The products to be reported during this portion of the meeting include: Paxil (paroxetine), Celexa (citalopram), Pravachol (pravastatin), and Navelbine (vinorelbine). Following this, from approximately 10:30 a.m. to 4:45 p.m., the subcommittee will discuss the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population.

On February 4, 2004, the subcommittee will meet between 8 a.m. and 12 noon to continue the discussion on the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population.

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 January 23, 2004. On February 3, 2004, oral presentations from the public will be scheduled between approximately 9:45 a.m. and 10:15 a.m. for issues related to the Section 17 adverse event reports. Also, on February 3, 2004, oral presentations from the public will be scheduled between approximately 3:45 p.m. and 4:45 p.m. for issues related to cardiac imaging in pediatric patients. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 23, 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]

horizonal rule