[Federal Register Volume 63, Number 58 (Thursday, March 26, 1998)]
[Notices]
[Page 14718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7897]
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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 will
be 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 regulatory issues.
Date and Time: The meeting will be held on May 13, 14, and 15,
1998, 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, 301-443-5455, 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 May 13, 1998, the committee will discuss the science of
corticosteroid induced osteoporosis. On May 14, 1998, the committee
will discuss new drug application (NDA) 20-866, ErgosetTM,
(bromocryptine mesylate, Ergoscience) as monotherapy as an adjunct to
diet to improve glycemic control in patients with non-insulin-dependent
diabetes mellitus, whose hyperglycemia cannot be satisfactorily managed
with diet alone; or concomitantly with a sulfonylurea when diet and
ErgosetTM alone do not result in glycemic control. On May
15, 1998, the committee will discuss NDA 20-898, ThyrogenTM,
(thyrotropin alpha, rTSH, Genzyme) as an adjunct for the detection of
thyroid cancer.
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 May 8, 1998.
Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m. on May 13, 14, and 15, 1998. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before May
8, 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: March 19, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-7897 Filed 3-25-98; 8:45 am]
BILLING CODE 4160-01-F
