Altabax Review Highlights Ethical Use Of Placebo In Pediatric Populations
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline’s pivotal trial for Altabax provided strong evidence that it could be ethical to use a placebo and withhold treatment for dermatological indications – even in a pediatric population – as long as safety measures were employed, FDA reviewers concurred.