[Federal Register Volume 62, Number 94 (Thursday, May 15, 1997)]
[Notices]
[Pages 26805-26806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12726]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 June 23, 1997, 8:30
a.m. to 4:30 p.m., and June 24, 1997, 9 a.m. to 4:30 p.m. An open
public hearing portion is scheduled from 8:30 a.m. to 9:30 a.m. on June
23, 1997.
Location: Holiday Inn--Bethesda, Versailles Ballrooms I and II,
8120 Wisconsin Ave., Bethesda, MD.
Contact Person: Jannette O'Neil-Gonzalez or Robinette Taylor,
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 June 23, 1997, the committee will discuss: (1) New drug
application (NDA) 20-709 for ZyrkamineTM (mitoguazone
dihydrochloride, ILEX Oncology), indicated for treatment of AIDS
(acquired immune deficiency syndrome)-related non-Hodgkin's lymphoma in
patients who have been previously treated with at least one
[[Page 26806]]
potentially curative regimen; and (2) NDA 20-262/S-022 for
Taxol for Injection Concentrate (paclitaxel, Bristol-Myers
Squibb Pharmaceutical Research Institute), indicated for second-line
treatment of AIDS-related Kaposi's sarcoma. On June 24, 1997, the
committee will discuss: (1) NDA 20-794 for LiazalTM Tablets
(liarozole fumarate, Janssen Research Foundation), indicated for
treatment of advanced prostate cancer in patients who relapsed after
first-line hormonal therapy; and (2) drafts of the FDA ``Guidance for
Industry: Providing Clinical Evidence of Effectiveness for Human Drug
and Biological Products'' and the FDA ``Guidance for Industry: FDA
Approval of New Cancer Treatment Uses for Marketed Drug and Biological
Products.'' These documents are available on the internet at http://
www.fda.gov/cder/guidance/htm or submit written requests for single
copies to the Drug Information Branch (HFD-210), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857.
Procedure: The meeting is open to the public. 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 6, 1997. Those desiring to make formal
presentations should notify the contact person before June 6, 1997, 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 required to
make their presentation.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-12726 Filed 5-14-97; 8:45 am]
BILLING CODE 4160-01-F
