![]() ![]() Comments submitted electronically, including attachments, to will be posted to the docket unchanged. Follow the instructions for submitting comments. Submit electronic comments in the following way: ![]() 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. Comments received after that date but by Octowill be taken into consideration by FDA. 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.Ĭomments received on or before Octowill be provided to the committee. Eastern Time at the end of October 27, 2022. The electronic filing system will accept comments until 11:59 p.m. Electronic comments must be submitted on or before October 27, 2022. Please note that late, untimely filed comments will not be considered. Submit either electronic or written comments on this public meeting by October 27, 2022. The docket will close on October 27, 2022. Interested persons may present data, information, or views, orally or in writing, on issues pending before the presiding officer and the committee.įDA is establishing a docket for public comment on this meeting. 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. 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. Meeting MaterialsįDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the meeting in the Event Materials section of this web page. The proposed indication (use) for this product is for the treatment of neuroblastoma with central nervous system/leptomeningeal metastases. TIMELY CALENDAR LICENSEThe committee will discuss biologics license application 761176, for 131I-omburtamab solution for injection, submitted by Y-mAbs Therapeutics, Inc. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |