Briefing Summary: US FDA Posts Advisory Committee Materials for Review of the Pediatric Safety of Certain Products and Discuss Upcoming Joint Meeting with the AADPAC and DSRM – APR 12, 2016

The US FDA has posted details, including FDA Briefing Materials, for the Tuesday, April 12, 2016 Pediatric Advisory Committee (PEDAC) meeting. The PEDAC will discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for FLULAVAL QUADRIVALENT (Influenza Virus Vaccine), FLULAVAL TRIVALENT (Influenza Virus Vaccine), FLUZONE QUADRIVALENT (Influenza Virus Vaccine). ACIPHEX SPRINKLES (rabeprazole sodium), MYCAMINE (micafungin sodium), NOXAFIL (posaconazole), PRECEDEX (dexmedetomidine hydrocholoride), SABRIL (vigabatrim), SEROQUEL (quetiapine fumarate) & SEROQUEL XR (quetiapine fumarate extended- release), SKYLA (levonorgestrel-releasing intrauterine system), SYMBAX (fluoxetine hydrocholoride and olanzapine), VYVANSE CAPSULES (lisdexamfetamine dimesylate), and XELODA (capecitabine).

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 the IMPELLA RP SYSTEM, LIPSORBER LA-15 SYSTEM, and MEDTRONIC ACTIVA DYSTONIA THERAPY.

In addition, FDA will be providing information on a proposed public advisory committee meeting for September 15 and 16, 2016, on appropriate pediatric development plans for prescription opioid drugs.

See the SAC Tracker report