[Federal Register Volume 63, Number 53 (Thursday, March 19, 1998)]
[Notices]
[Page 13413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7055]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy 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: Pulmonary-Allergy 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 April 20, 1998, 8 a.m.
to 5 p.m.
Location: Gaithersburg Hilton, Ballrooms C, D, and E, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: Leander B. Madoo, 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 12545. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss the safety and efficacy of new
drug application (NDA) 20-929 for Pulmicort RespulesTM
(budesonide suspension for nebulization, Astra USA) indicated for the
maintenance treatment of asthma and as prophylactic therapy in children
aged 6 months to 8 years. Pulmicort RespulesTM is also
indicated for children aged 6 months to 8 years with asthma who require
systemic corticosteroid administration where adding Pulmicort
RespulesTM may reduce or eliminate the need for systemic
corticosteroid administration.
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,
1998. Oral presentations from the public will be scheduled between
approximately 8:05 a.m. and 9:05 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before April 14, 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 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-7055 Filed 3-18-98; 8:45 am]
BILLING CODE 4160-01-F
