April 09, 2021

FDA and European Medicines Agency Develop Pediatric Oncology Drug Development Template

Regulators in the US and Europe have come together to provide a common template for drugmakers to use when planning clinical trials for pediatric drugs. The template provides a framework for seeking scientific advice from both the European Medicines Agency (EMA) and the FDA on new Pediatric Investigation Plans and initial Pediatric Study Plans, respectively.

The template lays out particular issues that each regulator will want to see the sponsors address. Areas covered by the template include overall development of the medicinal product, waivers, non-clinical studies and quality development issues. The FDA’s Oncology Center of Excellence and Office of Pediatric Therapeutics already collaborates closely with EMA in pediatric cluster calls.