EU/US plan 'challenging' new approach to developing Gaucher disease drugs
This article was originally published in SRA
Executive Summary
The European Medicines Agency and the US Food and Drug Administration are developing a "strategic collaborative approach" to the development of pediatric drugs for Gaucher disease that they say should help to generate the high-quality data required for the approval of new products while reducing the economic burden of conducting clinical trials1. Among other things, the new approach could involve potential competitors having to share confidential information, with one observer describing it as "a great idea but a challenge".