Before a new drug can be evaluated in children, paediatric study plan (PSP, in the USA) or a paediatric investigation plan (PIP, in the European Union) must be approved by regulatory authorities.
A PSP/PIP is a development plan that outlines the steps that will be taken to generate data to support approval of a drug or treatment in children.
PSP submission process
The process and timescale for submission of a PSP to the US Food and Drug Administration (FDA) is different. An initial PSP submission must be made at a specified point after phase 2 studies.
The FDA requires an initial PSP (iPSP) to be submitted no later than 60 days after the end-of-phase 2 meeting, unless it has agreed a different timescale with a sponsor. In the absence of an end-of-phase 2 meeting, an iPSP should be submitted as early as practicable but before the start of any phase 3 studies, or any combined phase 2 and phase 3 studies.
Often, an iPSP is drafted after end of phase 2 studies are completed but before the end of phase 2 meeting takes place. This means that the end of phase 2 meeting can include discussions of endpoints for both adult and paediatric studies.
Full details can be found on the FDA’s website.