Briefing Materials for the September 16, 2026 Meeting of the Pediatric Advisory Committee
Aranesp (darbepoetin alfa)
Dalvance (dalbavancin)
Enterra Therapy System (HDE)
Epicel (cultured epidermal autografts) Humanitarian Device Exemption (HDE)
Fragmin (dalteparin sodium)
Isopto Atropine (atropine sulfate)
Kloxxado nasal spray, Zimhi injection, Naloxone Hydrochloride Autoinjector, Naloxone hydrochloride nasal spray, RiVive nasal spray, Rezenopy nasal spray (naloxone hydrochloride)
Liposorber LA-15 System (HDE)
Lymphoseek (technetium Tc 99m tilmanocept)
Medtronic Activa Dystonia Therapy (HDE)
Medtronic Contegra Pulmonary Valved Conduit (HDE)
Minimally Invasive Deformity Correction (MID-C) System (HDE)
Nextstellis (drospirenone/estetrol)
Pleximmune (HDE)
Quelimmune (HDE)
Reflect Scoliosis Correction System (HDE)
Sonalleve MR-HIFU (HDE)
Sprycel (dasatinib)
Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate, magnesium sulfate)
Tecentriq (atezolizumab)
The Tether—Vertebral Body Tethering System (HDE)
Veklury (remdesivir)
Vemlidy (tenofovir alafenamide)
Zelsuvmi (berdazimer)
Zevtera (ceftobiprole medocaril sodium)
Zinplava (bezlotoxumab)