Pediatric Advisory Committee (PAC) - Notice of Meeting - Establishment of a Public Docket - Request for Comments

Sep 27, 2026

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Food and Drug Administration (FDA) announces a forthcoming public meeting of the Pediatric Advisory Committee (PAC), focused on pediatric regulatory issues. The meeting will be open to the public and conducted virtually on September 16, 2026, from 10:00 a.m. to 4:00 p.m. Eastern Time. FDA is establishing a public docket for comments, with the docket number FDA-2026-N-7514, accepting electronic or written submissions on or before September 15, 2026.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages7

Reading Time18 min

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Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments

Agency and action

Summary

Dates

Addresses and public access

Docket number and comment deadlines

How to submit electronic and written comments

Confidential submissions

This document is scheduled to be published in the Federal Register on 2026-07-28 and available online at [https://www.federalregister.gov/d/2026-15149](https://www.federalregister.gov/d/2026-15149), and on [https://govinfo.gov](https://govinfo.gov) DEPARTMENT OF HEALTH AND HUMAN SERVICES 4164-01-P Food and Drug Administration [Docket No. FDA-2026-N-7514] Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) . The general function of the committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held virtually on September 16, 2026, from 10:00 [a.m. to 4:00 p.m](a.m. to 4:00 p.m). Eastern Time (ET) . ADDRESSES: All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: [https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and](https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and)answers-about-fda-advisory-committee-meetings. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2026-N-7514 . The docket will close on September 15, 2026. Submit either electronic or written comments on this public meeting on or before September 15, 2026. Please note that late, untimely filed comments will not be considered. The [https://www.regulations.gov](https://www.regulations.gov electronic)[ electronic](https://www.regulations.gov electronic)[ ](https://www.regulations.gov electronic)[filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 15](filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 15), 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Comments received on or before September 9, 2026, 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: • Federal eRulemaking Portal: [https://www.regulations.gov. Follow the](https://www.regulations.gov. Follow the) instructions for submitting comments. Comments submitted electronically, including attachments, to [https://www.regulations.gov will be posted to the docket unchanged. Because your](https://www.regulations.gov will be posted to the docket unchanged. Because your)[ ](https://www.regulations.gov will be posted to the docket unchanged. 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. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on [https://www.regulations.gov](https://www.regulations.gov). • If you want to submit a comment with con

FAQs

What is the purpose of the Pediatric Advisory Committee meeting announced by FDA?

The meeting will provide advice and recommendations to FDA on pediatric regulatory issues.

When and how will the PAC meeting be held?

The meeting will be held virtually on September 16, 2026, from 10:00 a.m. to 4:00 p.m. Eastern Time.

What is the deadline to submit public comments to the docket?

Electronic or written comments must be submitted on or before September 15, 2026; late and untimely comments will not be considered.

Sep 27, 2026

Uploaded by Aurelia