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U.S. Department of Health and Human Services

Advisory Committees

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December 8, 2010: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDERDecember 8, 2010
 
8:00 a.m. to 11:30 a.m.
(Open Session)
12:30 p.m. to 3:30 p.m.
(Closed Session)
FDA White Oak Campus
Building 3, the Great Room, White Oak Conference Center (Rm. 1503)
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

Agenda

On December 8, 2010, from 8 a.m. to 11:30 a.m., the committee will discuss and provide general advice on the appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events (such as heart attacks) in patients with aspirin intolerance due to immunologically-based adverse reactions (adverse events related to immune system function), specifically in the setting of coronary artery bypass grafting (also referred to as "heart bypass surgery"). From 12:30 p.m. to 3:30 p.m. the committee will meet in closed session.

Closed Presentation of Date

On December 8, 2010, from 12:30 p.m. to 3:30 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)).

Meeting Materials

FDA intends to make open session 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.

Background Material

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 December 6, 2010.
  • On December 8, 2010 from 8 a.m. to 11:30 a.m., the meeting is open to the public. Oral presentations from the public will be scheduled between approximately 10 a.m. and 11 a.m., December 8, 2010. 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 November 29, 2010.

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 November 30, 2010.

Contact Information

  • Elaine Ferguson
    Center for Drug Evaulation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2440
    Silver Spring, Maryland 20993-0002
    Telephone: (301) 796-9001
    Fax: (301) 847-8533
    E-mail: elaine.ferguson@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Code: 3014512533
    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 Elaine Ferguson at (301) 796-9001 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 Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings

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