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Advisory Committee Meeting

Event Title
Pediatric Advisory Committee Meeting Announcement
September 15, 2020


Date:
September 15, 2020
Time:
10:00 AM - 4:30 PM ET

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.

Agenda

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On September 15, 2020, the Pediatric Advisory Committee (PAC) will meet to discuss the pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).  

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

  1. Center for Biologics Evaluation and Research
    a.    GAMUNEX-C (immune globulin intravenous (human)), 10%, Caprylate/Chromatography Purified
  2. Center for Devices and Radiological Health
    a.    FLOURISH Pediatric Esophageal Atresia Device (humanitarian device exemption)
  3. Center for Drug Evaluation and Research
    a.    ADZENYS ER (amphetamine) extended-release oral suspension
    b.    MYDAYIS (mixed salts of a single-entity amphetamine product) extended-release capsule, for oral use
    c.    ORENCIA (abatacept) for injection, for intravenous use
    d.    VYVANSE® (lisdexamfetamine dimesylate) capsule and chewable tablet

FDA will discuss acute dystonia associated with the use of attention deficit hyperactivity disorder (ADHD) medications (including methylphenidate products, amphetamine products, and atomoxetine).  Additionally, FDA will discuss acute hyperkinetic movement disorder associated with the combined use of ADHD stimulants and antipsychotics (including first-generation antipsychotics and second-generation antipsychotics).

Meeting Materials

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, all efforts will be made to try and provide the background material at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

Background Material

Public Participation Information

On September 15, 2020 from 10 a.m. to 4:30 p.m., 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-2020-N-1648.  The docket will close on September 14, 2020.  Submit either electronic or written comments on this public meeting by September 14, 2020.  Please note that late, untimely filed comments will not be considered.  Electronic comments must be submitted on or before September 14, 2020. The regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 14, 2020. 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 August 31, 2020 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 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 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-2020-N-1648 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 regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., 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 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: Consumer Comments—Public Posting and Availability of Comments Submitted to Food and Drug Administration Dockets.

Docket:  For access to the docket to read background documents or the electronic and written/paper comments received, go to Docket FDA-2020-N-1648 on regulations.gov  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 11:30 a.m. and 12:30 p.m. on September 15, 2020. 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 August 31, 2020. 

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 September 1, 2020.

Webcast Information

FDA plans to provide a free of charge, live webcast of the September 15, 2020 Meeting of the PAC. 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: 2020 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

Marieann Brill, MBA, RAC, MT(ASCP)
Office of Pediatric Therapeutics
Office of Clinical Policy and Programs
Office of the Commissioner
Food and Drug Administration
Bldg. 32, Room 5154
10903 New Hampshire Ave.
Silver Spring, Maryland 20993
Phone: 301–240-402-3838
Fax: 301-847-8640
E-mail: marieann.brill@fda.hhs.gov 

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities. If you require special accommodations due to a disability, please contact Marieann Brill (see CONTACT INFORMATION) at least 7 days in advance of the meeting.

Persons with disabilities having problems accessing any of the PDF files below may call 240-402-3838 for assistance.


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).


Event Materials

Title File Type/Size Source Organization
Webcast information, September 15, 2020 Pediatric Advisory Committee Meeting pdf (39.37 KB) Office of Clinical Policy and Programs
Jeffrey Strawn, M.D. - 18 U.S.C. 208(b)(3) Waiver pdf (78.82 KB) FDA
Jeffrey Strawn, M.D. - Acknowledgement of Financial Interest pdf (148.07 KB)
Adzenys Clinical Pharmacology Review pdf (4.04 MB) FDA
Adzenys Clinical Review pdf (1.93 MB) FDA
Adzenys and Mydayis Safety and Utilization Review pdf (504.09 KB) FDA
Mydayis Statistical Review pdf (4.21 MB) FDA
Mydayis Clinical Pharmacology Review pdf (4.37 MB) FDA
Mydayis Clinical Review pdf (2.24 MB) FDA
Mydayis Labeling pdf (353.02 KB) FDA
Mydayis Multidisciplinary Review Pediatric pdf (291.54 KB) FDA
Orencia Clinical Review pdf (299.68 KB) FDA
Orencia Clinical Review Addendum pdf (485.00 KB) FDA
Orencia Labeling pdf (1.45 MB) FDA
Orencia Clinical Pharmacology Review 1 pdf (2.34 MB) FDA
Orencia Clinical Pharmacology Review 2 pdf (280.01 KB) FDA
Orencia Safety and Utilization Review pdf (258.42 KB) FDA
Orencia Safety Signal Workup Review pdf (483.49 KB) FDA
Vyvanse Clinical Pharmacology Review pdf (1.24 MB) FDA
Vyvanse Clinical Review pdf (263.19 KB) FDA
Vyvanse Labeling pdf (836.57 KB) FDA
Vyvanse Safety and Utilization Review pdf (253.65 KB) FDA
Gamunex-C Clinical Pharmacology Review pdf (472.51 KB) FDA
Gamunex-C Clinical Review pdf (581.38 KB) FDA
Gamunex-C Labeling pdf (740.60 KB) FDA
Gamunex-C Safety and Utilization Review pdf (195.85 KB) FDA
Flourish Labeling 1 pdf (283.99 KB) FDA
Flourish Labeling 2 pdf (169.42 KB) FDA
Flourish Executive Summary pdf (751.71 KB) FDA
Pediatric Advisory Committee (PAC) September 15, 2020 Draft Agenda pdf (215.12 KB) FDA
ADHD Stimulants and Atomoxetine & Antipsychotics Integrated Postmarket Safety Review pdf (849.18 KB) FDA
ADHD Stimulants and Atomoxetine Integrated Postmarket Safety Review pdf (1.41 MB) FDA

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