FDA: adult trials data may suffice for paediatric uses
This article was originally published in Clinica
Executive Summary
The US FDA says it will not necessarily require clinical data from companies seeking to market a product for paediatric use. The amount and type of evidence required will depend on the nature of the device, what is known about the product in the adult population, what is known about the device to the paediatric population and the underlying disease or condition being treated, the agency said.