A pivotal chapter in US regulatory history
This article was originally published in Scrip
Executive Summary
The FDA yesterday took a step towards reclaiming a unified title as the gold standard in drugs regulation. At the core of the agency’s decision was its aim of achieving better transparency for all parties. The FDA has decided to restrict GlaxoSmithKline’s type-2 diabetes medicine Avandia, but allow it to stay on the market as a last resort for some patients.