[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Notices]
[Page 54118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27529]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous System 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: Peripheral and Central Nervous System Drugs
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on regulatory issues.
Date and Time: The meeting will be held on November 18 and 19,
1997, 8:30 a.m. to 5 p.m.
Location: Quality Hotel, Maryland Ballroom, 8727 Colesville Rd.,
Silver Spring, MD.
Contact Person: Ermona McGoodwin or Danyiel D'Antonio, 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 12543. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On November 18, 1997, the Committee will discuss the
evidence of safety and effectiveness in new drug application (NDA) 20-
861, Prosynap (lubeluzole injection, Janssen Research Foundation) for
the treatment of acute ischemic stroke in adults. On November 19, 1997,
the Committee will discuss the evidence of safety and effectiveness in
NDA 20-764, Lamictal CD Chewable Dispersible Tablets (lamotrigine,
Glaxo Wellcome) for the treatment of the generalized seizures of
Lennox-Gastaut syndrome in pediatric and adult patients.
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 November 12,
1997. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on November 18, 1997, and between 9
a.m. and 10 a.m. on November 19, 1997. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before November 12,
1997, 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: October 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-27529 Filed 10-16-97; 8:45 am]
BILLING CODE 4160-01-F