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| Center | Date | Time | Location |
|---|---|---|---|
| CDER | June 10, 2003 | 8:30 a.m. - 5:00 p.m. | Holiday Inn |
Agenda:
The committee will discuss supplemental new drug application (sNDA) 19-604/S-033,
HUMATROPE (somatropin recombinant deoxyribonucleic acid (rDNA) origin for injection),
Eli Lilly and Co., for the proposed indication of treatment of nongrowth hormone
deficiency short stature.
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 3, 2003. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. - 2:30 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before June 3, 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 Dornette Spell-LeSane at least 7 days in advance of the meeting.
Contact Person:
Dornette Spell-LeSane, 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, FAX: 301-827-6776,
email: spelllesaned@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12536. Please call the Information Line for up-to-date
information on this meeting.
[Full FR Notice] [Amended FR Notice]