Advisory Committees

November 19, 2015: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement

UPDATED INFORMATION
The Agenda portion has been changed for the November 19, 2015 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. There are no other changes.

The Agenda portion is changed to read as follows:
Information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ABT-414, sponsored by AbbVie, Inc., and (2) Lenvatinib, sponsored by Eisai, Inc.

ORIGINAL INFORMATION

CenterDateTimeLocation
CDERNovember 19, 2015
 
8:00 a.m. to 1:00 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

Information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ABT-414, submitted by AbbVie, Inc., and (2) Lenvatinib, submitted by Eisai, Inc.

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 is available at: 2015 Meeting Materials, Oncologic Drugs Advisory Committee

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 4, 2015.
  • Oral presentations from the public will be scheduled between approximately 9:05 a.m. to 9:35 a.m., and 11:30 a.m. to 12:00 p.m. on November 19, 2015. Those individuals interested in making 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 27, 2015.

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 28, 2015.

Webcast Information

CDER plans to provide a free of charge, live webcast of the November 19, 2015 meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. 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: 2015 Meeting Materials, Oncologic 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

  • Lauren D. Tesh, PharmD, BCPS
    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
    Email: ODAC@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 disabilities. If you require accommodations due to a disability, please contact Lauren D. Tesh at 301-796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

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).

Page Last Updated: 09/22/2015
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