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U.S. Department of Health and Human Services

Advisory Committees

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CANCELLED March 27, 2012: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER March 27, 2012
 
8:00 a.m. to 5:00 p.m. FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland

Agenda

On March 27, 2012, from 11:00 a.m. to 5:00 p.m. the committee will discuss biologics license application (BLA) 125410, proposed tradename REPLAGAL (agalsidase alfa), submitted by Shire Human Genetics Therapies, for an enzyme replacement therapy (ERT) for patients with Fabry disease.

Closed Presentation of Data

On March 27, 2012, from 8:00 a.m. to 10:45 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c) (4)). During this session, the committee will discuss confidential manufacturing information.

Meeting Materials

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.

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 March 13, 2012.
  • Oral presentations from the public will be scheduled between approximately 2:10 p.m. to 3:10 p.m. 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 March 5, 2012.

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 March 6, 2012.

Webcast Information

CDER plans to provide a free of charge, live webcast of the March 27, 2012 meeting of the Cardiovascular and Renal Drugs Advisory Committees. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2012 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • Kristina A. Toliver, PharmD
    Center for Drug Evalulation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2417
    Silver Spring, Maryland 20993-0002
    Telephone: (301) 796-9001
    Fax: (301) 847-8533
    E-mail: CRDAC@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    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 FDA Advisory Committee Information Line to learn about possible modifications before coming to 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 Kristina Toliver at (301) 796-9001 at least 7 days in advance of the meeting.

Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.

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).