May 11-12, 2022: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement – 05/11/2022 | FDA – FDA.gov

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Advisory Committee Meeting

 
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On May 11, 2022, the subcommittee will discuss the development of a conceptual framework that will inform the decision-making of the FDA on sponsor plans and requests for waivers of early pediatric investigations of molecularly-targeted cancer drugs and biologics when multiple same-in-class products are approved and/or in development, recognizing that the rarity of pediatric cancers may preclude the feasibility of investigations of multiple products. Investigation of more than one product may be appropriate when specific product characteristics predict an improved benefit-risk assessment that warrants clinical investigation.
On May 12, 2022, the subcommittee will consider and discuss the potential utility and steps to validation of an intermediate clinical endpoint, response to induction therapy, in the development of new drugs for the first-line treatment of patients with high-risk neuroblastoma. The European Medicines Agency (EMA) has also been invited to present on both days.
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 website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the live webcast will be available at: 2022 Meeting Materials, Oncologic Drugs Advisory Committee. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2021-N-1302. The docket will close on May 10, 2022. Submit either electronic or written comments on this public meeting by May 10, 2022. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 10, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 10, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Comments received on or before April 27, 2022, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Written/Paper Submissions
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2021-N-1302 for “Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Oral presentations from the public will be scheduled between approximately 1:45 p.m. to 2:15 p.m. Eastern Time on May 11, 2022. Oral presentations from the public will also be scheduled between approximately 2 p.m. to 2:30 p.m. Eastern Time on May 12, 2022. 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 April 19, 2022.
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 April 20, 2022.
CDER plans to provide a free of charge, live webcast of the May 11-12, 2022 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. If 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: 2022 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.
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 or call the committee’s Designated Federal Officer (see Contact Information) 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 the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability 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).
04/08/2022
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