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Advisory Committee Meeting | In Person

Event Title
September 14, 2016: Pediatric Advisory Committee Meeting Announcement
September 14, 2016

Date:
September 14, 2016

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.

DateTimeLocation
September 14, 20168:00 a.m. – 5:30 p.m.DoubleTree by Hilton Hotel
Bethesda-Washington D.C.
8120 Wisconsin Avenue
Bethesda, MD 20814
301-652-2000

Agenda

On Wednesday, September 14, 2016, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for MENVEO [Meningococcal (groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine], IXIARO (Japanese encephalitis vaccine), ASACOL, ASACOL HD (mesalamine), BLOXIVERZ (neostigmine methylsulfate), DELZICOL (mesalamine), DORYX (doxycycline hyclate), KARBINAL ER (carbinoxamine maleate), KEPIVANCE (palifermin), SUSTIVA (efavirenz), TOPAMAX (topiramate), and XOLAIR (omalizumab).

As mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for: BERLIN HEART EXCOR® Pediatric Ventricular Assist Device (VAD), CONTEGRA® Pulmonary Valved Conduit, ELANA SURGICAL KIT (HUD), CONTEGRA PULMONARY VALVED CONDUIT, ENTERRA™ THERAPY SYSTEM, and PLEXIMMUNE.

In addition, the FDA will also provide an update of their additional ongoing analysis of a possible safety signal regarding the use of the drug product, Exjade (deferasirox) in children with fever and dehydration.

Meeting Materials

FDA intends to make the complete set of 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

2016 Meeting Materials, Pediatric Advisory Committee Public Participation and Sponsor Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 7, 2016. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 9:30 a.m. on September 14, 2016. 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 30, 2016. 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 August 31, 2016.

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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Marieann Brill at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings.

Starting on September 12, 2016 through September 23, 2016, a second docket, FDA-2016-N-2470, has been established to receive public input on these additional mandated pediatric safety review for: LYSTEDA (tranexamic acid), BARACLUDE (entecavir), ISENTRESS (raltegravir potassium), and SALONPAS Relief (methyl salicylate 10% and 1-menthol 3%P Patch). Review documents and the docket links will be available at Web-Posted Pediatric Safety Reviews.

Contact Information

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

  • FDA Advisory Committee Information Line 1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Code: 8732310001
    Please call the Information Line for up-to-date information on this meeting.

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

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).

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