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U.S. Department of Health and Human Services

Advisory Committees

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November 18, 2009: Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDERNovember 18, 2009
 
8:00 a.m. - 5:00 p.m.
 
Hilton Washington DC North/Silver Spring, MD
The Ballrooms
8727 Colesville Road
Silver Spring, Maryland
Telephone: 301-589-5200

Agenda

On November 18, 2009, the Committee will discuss biologic license application (BLA) # 103976, Supplement # 5149 for Xolair (omalizumab), manufactured by Genentech/Novartis.  The proposed indication for this product is to treat moderate to severe persistent asthma in patients between 6 and 11 years of age whose symptoms are inadequately controlled with inhaled steroid medications and have (a) a positive reaction to skin testing with common substances that can cause allergies and asthma, such as pollen, or (b) in vitro reactivity, which is measured with a blood test that confirms the presence of specific proteins consistent with allergies and asthma.

Meeting Materials

FDA intends to make the complete background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.  

Public Participation Information

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 on or before November 3, 2009.
  • Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m on November 18.  Those desiring to make formal oral presentations should notify the contact person 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 on or before October 26, 2009.

Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by October 27, 2009.

Contact Information

  • Kristine T. Khuc
    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
    Phone: 301-827-7001
    Fax: 301-827-6776
    E-mail: Kristine.Khuc@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Code: 3014512545
    Please call the Information Line for up-to-date information on this meeting

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

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 Kristine Khuc at (301) 827-7001 at least 7 days in advance of the meeting.  FDA is committed to the orderly conduct of its advisory committee meetings.

Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).