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Pulmonary-Allergy Drugs Advisory Committee

Agenda:
On July 13, 2005, the committee will discuss the implications of recently available data related to the safety of long-acting beta-agonist bronchodilators.

On July 14, 2005, the committee will discuss the continued need for the essential use designations of prescription drugs for the treatment of asthma and chronic obstructive pulmonary disease under 21 CFR 2.125.

Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).

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 July 1, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on July 13, 2005, and between approximately 11 a.m. and 12 noon on July 14, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 1, 2005, 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. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

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 La'Nise Giles at 301-827-7001 at least 7 days in advance of the meeting.

Contact Person:
Teresa A. Watkins, 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, e-mail: watkinst@cder.fda.gov.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512545.