Anti-Infective Drugs Pediatric Subcommittee to Meet
05/13/2004
Federal Register Notice: FDA’s Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee will meet 6/9, from 8 a.m. to 5 p.m. at the CDER Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD. The subcommittee will hear an agency report on adverse event reporting for Hycamtin, Temodar, Effexor, Monopril, Allegra, Duragesic, Ciloxan, and Vigamox. The agency will also provide an update on neonatal withdrawal syndrome and congenital eye malformations reported in infants whose mothers used selective serotonin reuptake inhibitors during pregnancy. From 3:30 p.m. to 4 p.m., the agency will provide an overview of the Pediatric Research Equity Act. From 4 p.m. to 4:30 p.m., there will be an overview of the Institute of Medicine report entitled “Ethical Conduct in Pediatric Clinical Trials.” And from 4:30 p.m. to 4:45 p.m., the agency will provide an update on the Subpart D, institutional review board referral process. Contact Thomas H. Perez, (301) 827-7001. To view this notice, click here.
