Advisory Committee Meeting | Virtual

Event Title

Pediatric Advisory Committee Meeting Announcement

July 9, 2025

Date:: July 9, 2025
Time:: 10:00 a.m. - 4:00 p.m. ET

What is an advisory committee?

Advisory 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. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

Center: Office of the Commissioner

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.

Agenda

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 9, 2025, the Pediatric Advisory Committee (PAC) will meet to discuss post-marketing pediatric-focused safety reviews as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109), the Pediatric Research Equity Act of 2003 (Pub. L. 108-155), and the Pediatric Medical Device Safety and Improvement Act of 2007 (Pub. L. 110-85, title III).

The PAC will have the opportunity to ask the Agency clarifying questions and to convey their recommendations for safety monitoring of the products listed below. The scope of the discussion will be limited to post-marketing safety and surveillance activities. No information is required from product sponsors.

The PAC will meet to discuss the following products listed by FDA Center:

1. Center for Devices and Radiological Health

a. LIPOSORBER LA-15 SYSTEM (Humanitarian Device Exemption (HDE))
b. MEDTRONIC ACTIVA NEUROSTIMULATOR FOR DYSTONIA TREATMENT (HDE)
c. MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM (HDE)
d. REFLECT SCOLIOSIS CORRECTION SYSTEM (HDE)
e. THE TETHER – VERTEBRAL BODY TETHERING SYSTEM (HDE)

2. Center for Biologics Evaluation and Research

a. DENGVAXIA (Dengue Tetravalent Vaccine, Live)
b. EPICEL (cultured epidermal autografts) (HDE)
c. FLUZONE QUADRIVALENT (Influenza Vaccine)
d. GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

3. Center for Drug Evaluation and Research

a. AUVI-Q AUTO-INJECTOR (epinephrine)
b. DIOVAN (valsartan)
c. ENTRESTO (sacubitril and valsartan)
d. ERAXIS (anidulafungin)
e. EUCRISA (crisaborole)
f. EXJADE (deferasirox), JADENU (deferasirox) and JADENU SPRINKLE (deferasirox)
g. FIASP (insulin aspart)
h. JAKAFI (ruxolitinib phosphate) and OPZELURA (ruxolitinib)
i. LATUDA (lurasidone hydrochloride)
j. LILETTA (levonorgestrel-releasing intrauterine system)
k. MYCAMINE (micafungin)
l. NITYR (nitisinone)
m. POTASSIUM PHOSPHATES (potassium phosphate, dibasic injection; potassium phosphate, monobasic)
n. REPATHA (evolocumab)
o. ROZLYTREK (entrectinib)
p. STELARA (ustekinumab)
q. SUTENT (sunitinib malate)
r. TASIGNA (nilotinib)
s. TOPICORT (desoximetasone)
t. TRIUMEQ (abacavir, dolutegravir, lamivudine) and TRIUMEQ PD (abacavir, dolutegravir, lamivudine)
u. XYREM (sodium oxybate)

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting at this site: 2025 Meeting Materials, Pediatric Advisory Committee.

Public Participation Information

On July 9, 2025, from 10:00 a.m. to 3:30 p.m. Eastern Time (ET), the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2025-N-1246. The docket will close on July 8, 2025. Submit either electronic or written comments on this public meeting by July 8, 2025. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 9, 2025.

The https://www.regulations.gov electronic filing system will accept comments until 11:59 P.M. Eastern Time at the end of July 8, 2025. 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 July 2, 2025, will be provided to the committee. Comments received after the date will be taken into consideration by FDA. 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. You may submit your comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: 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 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.
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submission as follows:

Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include Docket No. FDA-2025-N-1246. for “Pediatric Advisory Committee; 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. ET, Monday through Friday, 240-402-7500.

Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/app/details/FR-2015-09-18/2015-23389/summary

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 10:30 a.m. and 11:30 a.m. ET on July 9, 2025. 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 June 24th, 2025.

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 June 25, 2025.

Webcast Information

FDA plans to provide a free of charge, live webcast of the July 9, 2025, Pediatric Advisory Committee meeting. There are instances where the webcast transmission is not successful; the 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: 2025 Meeting Materials, Pediatric Advisory Committee.

FDA plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

Shivana Srivastava, RN, MS, PMP
Designated Federal Officer, Pediatric Advisory Committee
Office of Pediatric Therapeutics
Office of the Chief Medical Officer
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Bldg. 32, Rm. 5157
Silver Spring, Maryland 20993
Phone: 301-796-8695
E-mail: Shivana.srivastava@fda.hhs.gov
FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area) – follow the prompts to the desired center or product area
Please call the Information Line for up-to-date information on this meeting.
For press inquiries, please contact the HHS Press Room at www.hhs.gov/press-room/index.html or 202-690-6343.

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.

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).

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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).