A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007-2013

Conclusion:
Despite the different legal frameworks, criteria, and processes of determination, the waiver decisions of the 2 agencies were similar in the majority of cases.

Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Egger, G. F., Wharton, G. T., Malli, S., Temeck, J., Murphy, M. D., Tomasi, P. Tags: Special Populations Source Type: research