Oncology Benefits Most From EMA-FDA Pediatrics 'Cluster' Informal Advice

20 Oct 2015

FDA and EMA staffers talk monthly on topics related to pediatric uses, resulting in 15 non-binding joint commentaries.

Oncology and gastroenterology products so far are benefiting the most from a relatively new collaboration between the European Medicines Agency and the US FDA to provide informal parallel scientific advice to developers of selected pediatric medicines under review at both agencies.

Under the collaboration, the pediatric "cluster" of EMA and FDA officials holds monthly teleconferences to discuss product-specific or general pediatric...