I thought I would post this in case anyone is interested in attending the meeting.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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's regulatory issues.
Date and Time: The meeting will be held on May 15, 2003, from 8
a.m. to 5 p.m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Contact Person: Kimberly Littleton Topper, 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 20857, 301-827-7001, 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 biologics license application
(BLA) 103976, XOLAIR Omalizumab (Humanized Monoclonal Antibody to Human
IgE) by Genentech, Inc., for the treatment of allergic asthma.
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, 2003.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before May 8, 2003, 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
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kimberly Littleton
Topper at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
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