Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

[Federal Register Volume 64, Number 25 (Monday, February 8, 1999)]
[Notices]
[Page 6100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2852]


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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 March 26, 1999, 8 a.m. 
to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., 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, Rockville, MD 20857, 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: The committee will discuss experience since approval for 
marketing, benefits, and risks of RezulinTM (troglitazone, 
Parke-Davis Pharmaceutical Research, a Division of Warner-Lambert) in 
the treatment of 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 March 23, 
1999. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9:30 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 23, 1999, 
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. In addition, an open public session will be 
conducted after the scientific presentations.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 26, 1999.
 Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-2852 Filed 2-5-99; 8:45 am]
BILLING CODE 4160-01-F