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U.S. Department of Health and Human Services

Advisory Committees

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July 29, 2010: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDERJuly 29, 2010
 
8:00 a.m. to 5:00 p.m.
 
University of Maryland
Marriott Conference Centers
UMUC Inn and Conference Center by Marriott
3501 University Boulevard East
Adelphi, Maryland 20783
Telephone: (301) 985–7300

Agenda

On July 29, 2010, the committee will discuss Revatio (sildenafil) for the treatment of pediatric pulmonary arterial hypertension (PAH) and whether to amend the clinical trials section of the written request, issued by FDA to Pfizer, to include assessment of a hemodynamic endpoint. An area of particular interest will be what the appropriate study endpoint should be in patients with PAH unable to perform exercise testing. The discussion will help the agency determine what studies to request for products intended to treat pediatric PAH.

Meeting Materials

Links to meeting materials will be added as they become available.

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 July 14, 2010
  • Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m., July 29, 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 July 6, 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 July 7, 2010.

Contact Information

  • Elaine Ferguson
    E-mail: Elaine.Ferguson@fda.hhs.gov

    Elaine Ferguson c/o Christine Shipe
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2419
    Silver Spring, Maryland 20993-0002
    Telephone: (301) 796-9001
    Fax: (301) 847-8532
     
  • 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.

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