Federal Register
Notice: FDA’s Pediatric Advisory Committee will meet 3/22, from 8 a.m. to 6 p.m. at Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD. The committee will hear and discuss a report by the agency on adverse event reports possibly related to clofarabine (Clolar), irbesartan (Avapro), sibutramine (Meridia), and the mixed salts amphetamine product (Adderall). In continuation of a prior committee discussion of adverse events for the class of methylphenidate products used to treat ADHD, the committee will hear and discuss neuropsychiatric adverse events possibly related to other approved ADHD medications. The presentations will focus on neuropsychiatric adverse event reports and clinical trial data from approved ADHD medications. The committee will also receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD medications. Contact Jan N. Johannessen, (301) 827-6687. To view this notice, click here.