FDA Pediatric Advisory Committee Meeting Will Review Exjade

August 25, 2015 – On Wednesday, September 16, the Pediatric Advisory Committee (PAC) of the U.S. Food and Drug Administration (FDA) will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA) for several drugs. Included on the list of drugs to be reviewed is Exjade (Deferasirox), the oral iron chelator which is used by many thalassemia patients.

The Cooley’s Anemia Foundation (CAF) is informing the thalassemia community about this meeting in the event that any individuals interested in expressing their views on pediatric safety issues related to Exjade may have the opportunity to do so.

CAF will be attending the meeting and requesting the opportunity to present oral testimony on behalf of the Foundation.

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 8, 2015. Oral presentations from the public will be scheduled between approximately 9:00 a.m. and 10:00 a.m. on September 16, 2015. Those individuals interested in making formal oral presentations should notify the contact person (below) 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 September 1, 2015.

The full notice concerning this meeting can be accessed at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm458357.htm.

Those wishing to make a written or oral presentation should contact:

Walter Ellenberg, Ph.D.
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: 301–796-0885
Fax: 301-847-8640
E-mail: walter.ellenberg@fda.hhs.gov

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