The US FDA has posted details, including FDA Briefing Materials, for the Wednesday, September 14, 2016 Pediatric Advisory Committee (PEDAC) meeting. The PEDAC Committee will 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), 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.
See the SAC Tracker report