[Federal Register Volume 64, Number 52 (Thursday, March 18, 1999)]
[Notices]
[Pages 13431-13432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6531]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Endocrinologic and Metabolic 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 is
open to the public.
Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 22 and 23, 1999, 8
a.m. to 5 p.m.
Location: Pook's Hill Marriott, Ballroom, 5151 Pook's Hill Rd.,
Bethesda, MD.
Contact Person: Kathleen R. Reedy or LaNise S. Giles, 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, 301-827-7001, 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.
Agenda: On April 22, 1999, the committee will discuss the safety
and efficacy of new drug application (NDA) 21-071, AvandiaTM
(rosiglitazone, SmithKline Beecham) for the treatment of hyperglycemia
in type 2 diabetes mellitus, as monotherapy and in combination with
metformin. On April 23, 1999, the committee will discuss the safety and
efficacy of NDA 21-073, ActosTM (pioglitazone, Takeda
Pharmaceuticals) to improve glycemic control in patients with type 2
diabetes mellitus.
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 April 14,
1999. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before April 14, 1999, and
[[Page 13432]]
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: March 3, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-6531 Filed 3-17-99; 8:45 am]
BILLING CODE 4160-01-F
