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U.S. Department of Health and Human Services

Advisory Committees

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March 14, 2012: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement

Center Date Time Location
CDER March 14, 2012
 
7:30 a.m. to 3:00 p.m.
 

Gaylord National Hotel and

Convention Center

Maryland Ballroom C

201 Waterfront Street

National Harbor, Maryland

Agenda

On March 14, 2012, the committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. The discussion will include the role of modeling and simulation including physiologically-based pharmacokinetic modeling in pediatric drug development. Modeling and simulation is the application of mathematical approaches to predicting what will happen in a clinical trial with pediatric patients when a particular dose of a drug is used.

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 February 29, 2012.
  • Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 11:15 a.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 February 21, 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 February 22, 2012.

Webcast Information

CDER will not be providing a webcast of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology meeting.

Contact Information

  • Yvette Waples, Pharm.D.
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2417
    Silver Spring, MD 20993-0002
    Phone: 301-796-9001
    Fax: 301-847-8533
    E-mail: ACPS-CP@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 Web site 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 Yvette Waples 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 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).