November 4, 2013: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement
|CDER||November 4, 2013||1:00 p.m. to 5:00 p.m.||FDA White Oak Campus|
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
The recent permanent reauthorization of the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) and their associated amendments require earlier consideration of pediatric study plans. The need for suitable outcome assessment tools to evaluate treatment benefit of new cancer drugs on how a patient feels and/or functions as well as survives necessitates consideration of the potential challenges to the use of patient reported outcomes (PROs) in the pediatric age group. The 2009 “FDA Guidance for Industry: Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims” does not specifically address the relevance and potential use of such measures in the pediatric development plans of oncology products. The half-day session will provide an opportunity to review the Agency’s position on the use of PROs in the pediatric population in general. As well, participants will review the current state of the science of the evaluation of pertinent health-related quality of life measures in children with cancer across the various age and developmental subgroups of children. Participants will discuss potential contexts of use for measuring both observable and unobservable concepts in specific pediatric cancer diagnoses across relevant age groups and defined disease stages using validated tools. No specific drug or biologic products or class of products will be discussed.
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.
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 October 30, 2013.
- Oral presentations from the public will be scheduled between approximately 2:45 p.m. to 3:45 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 October 28, 2013.
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 29, 2013.
CDER plans to provide a free of charge, live webcast of the November 4, 2013, 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: 2013 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.
- Caleb Briggs, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- 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 Caleb Briggs 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).