[Federal Register: March 18, 1999 (Volume 64, Number 52)]
[Notices]               
[Page 13431-13432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr99-89]

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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, Avandia<SUP>TM</SUP> 
(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, Actos<SUP>TM</SUP> (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