Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and inconsistencies regarding the PIP document. In the USA, the Food and Drug Administration Safety and Innovations Act (FDASIA) has effectively made it mandatory to submit a paediatric study plan (PSP, the US equivalent of a PIP) soon after completion of phase II of development. Drug companies will need to work out how best to manage having two approved plans in parallel and avoid discrepancies.
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