Topic: Pediatric Study Plan (PSP)
Writing Pediatric Study Plans (PSPs) - The Impact of the Revised 2016 FDA Draft Guidance
An initial Pediatric Study Plan (iPSP) is an outline of the paediatric study or studies that the drug development sponsor plans to conduct in the US to confirm the suitability...
Author: Diana Radovan and Rachel Beeby
Journal: Journal for Clinical Studies
Date: 2018 - Volume 10 - Issue 4