Federal Register Notice: FDA’s Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee will meet 2/3, from 9 a.m. to 4:45 p.m., and 2/4, from 8 a.m. to 12 noon at the CDER Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD. On 2/3 the agency will report to the subcommittee on Adverse Event Reporting as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA). The products to be reported during this portion of the meeting include: Paxil (paroxetine), Celexa (citalopram), Pravachol (pravastatin), and Navelbine (vinorelbine). The subcommittee will then discuss the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population. On 2/4, the subcommittee will continue the discussion on the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population. Contact Thomas H. Perez, (301) 827-7001. To view this notice, click here.
