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FDA Home Page | Search FDA Site | A-Z Index | Contact FDA
| Center | Date | Time | Location |
|---|---|---|---|
| CDER | June 10, 2003 | 8:30 a.m. - 5:00 p.m. | Center for Drug
Evaluation and Research |
Agenda:
The committee will review and discuss issues relating to the format and content
of genome scale gene expression data generated during nonclinical pharmacology
and toxicology investigations and the submission of this data to the agency.
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 2, 2003. Oral presentations from the public will be scheduled
between approximately 1:00 p.m. and 2:00 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before June 2, 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 Kimberly Topper at least 7 days in advance of the meeting.
Contact Person:
Kimberly Topper, Center for Drug Evaluation and Research (HFD-21), Food and
Drug Administration (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville,
MD 20857, (301) 827-7001, or e-mail: topperk@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12539. Please call the Information Line for up-to-date
information on this meeting.