[Federal Register Volume 62, Number 242 (Wednesday, December 17, 1997)]
[Notices]
[Page 66113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32874]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal 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: Cardiovascular and Renal 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 January 27, 1998, 8:30
a.m. to 5:30 p.m.; and January 28, 1998, 9 a.m. to 4 p.m.
Location: National Institutes of Health, Natcher Conference Center,
45 Center Dr., Bethesda, MD 20892.
Contact Person: Joan C. Standaert, Center for Drug Evaluation and
Research (HFD-110), 419-259-6211, or Danyiel A. D'Antonio (HFD-21),
301-443-5455, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 12533. Please
call the Information Line for up-to-date information on this meeting.
Agenda: On January 27, 1998, the committee will review and discuss:
(1) New drug application (NDA) 20-736, VerdiaTM (tasosartan,
Wyeth-Ayerst Research), as a therapy for hypertension; and (2) the
unapproved outpatient use of intermittent intravenous positive
inotropic agents. On January 28, 1998, the committee will review and
discuss NDA 20-718, IntegrilinTM (eptifibatide, Cor
Therapeutics, Inc.), for use in the settings of percutaneous
transluminal angioplasty and acute coronary syndrome.
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 20,
1998. Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9:30 a.m. on January 27, 1998. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
January 20, 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: December 11, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-32874 Filed 12-16-97; 8:45 am]
BILLING CODE 4160-01-F
