Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. 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: You may submit your comments as follows: Electronic Submissions In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications of information, and consider any comments submitted to the docket, as appropriate. Comments received after the date will 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 Septemwill be provided to the committee. Eastern Time at the end of September 18, 2023.

The electronic filing system will accept comments until 11:59 P.M.

Electronic comments must be submitted on or before September 18, 2023. Please note that late, untimely filed comments will not be considered. Submit either electronic or written comments on this public meeting by September 18, 2023. The docket will close on September 18, 2023. Interested persons may present data, information, or views, orally or in writing, on issues pending before 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 available to the public no later than 2 business days before the meeting at this site: 2023 Meeting Materials, Pediatric Advisory Committee. On September 20, 2023, the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. The discussion will be limited to the use of AWT as an alternative to current standard-of-care management of extremely premature infants in the Neonatal Intensive Care Unit. On September 19, 2023, the Pediatric Advisory Committee (PAC) will meet to discuss the appropriate development plans for establishing safety and effectiveness of artificial womb technology (AWT) devices, including regulatory and ethical considerations for first in human (FIH) studies. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. Location: All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform. Please see, ' Advisory Committees Give FDA Critical Advice and the Public a Voice,' for more information. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Date: September 19 - 20, 2023 Day1: Tue, Sep 19 9:00 AMĪdvisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science.

Make out session on first date