Pediatric placebo-controlled trials
Executive Summary
Pediatric subcommittee of the Anti-Infective Drugs Advisory Committee will meet Sept. 11 to discuss ethical considerations in the conduct of placebo-controlled clinical trials in the pediatric population. The subcommittee will also consider the development of psychotropic drugs for use in young children (1"The Pink Sheet" March 27, p. 26). The meeting will begin at 8 a.m. at the Hyatt Regency in Bethesda, Md
You may also be interested in...
FDA Pediatric Therapeutics Office To Consider Ethics, Postmarket Safety
FDA is in the process of hiring an epidemiologist to coordinate epidemiology and safety reviews of approved pediatric products within the newly created Office of Pediatric Therapeutics
FDA Pediatric Cmte. To Discuss Psychotropic Drug Protocols For Preschoolers
FDA's Pediatric Advisory Subcommittee is expected to discuss appropriate study designs for testing the use of psychotropic drugs in a preschool population at its September meeting.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011