[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Notices]
[Pages 8461-8462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4079]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Oncologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on March 19 and 20, 1998,
from 8 a.m. to 5 p.m.
Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave.,
Bethesda, MD.
Contact Person: Karen M. Templeton-Somers or Adele S. Seifried,
Center for Drug Evaluation and Research (HFD-21), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 12542. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On March 19, 1998, the committee will discuss: (1) New drug
application (NDA) supplement 20-509/S-005 Gemzar (gemcitabine
HCl), Eli Lilly and Co., indicated as a single agent or in combination
with cisplatin for the first-line treatment of patients with locally
advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell
lung cancer; and (2) NDA 20-896 XelodaTM (capecitabine)
tablets, Hoffman-La Roche Inc., indicated for the treatment of patients
with locally advanced or metastatic breast cancer after failure of
paclitaxel and an anthracycline-containing chemotherapy. On March 20,
1998, the committee will discuss: (1) NDA supplement 20-262/S-026
Taxol (pacletaxel) injection, Bristol-Myers Squibb
Pharmaceutical Research Institute, indicated as first-line therapy for
the treatment of advanced carcinoma of the ovary; and (2) NDA
supplement 20-262/S-024 Taxol (pacletaxel) injection,
Bristol-Myers Squibb Pharmaceutical Research Institute, indicated for
the treatment of non-small cell lung cancer in patients who are not
candidates for potentially curative and/or radiation therapy.
[[Page 8462]]
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 February 26,
1998. Oral presentations from the public will be scheduled between
approximately 8 a.m. and 9 a.m., on March 19, 1998, and 8 a.m. and 8:30
a.m. on March 20, 1998. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before February 26, 1998, 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C., app. 2).
Dated: February 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-4079 Filed 2-18-98; 8:45 am]
BILLING CODE 4160-01-F
