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Court ruling means firms could face greater paediatric studies obligation beyond intended indication

This article was originally published in Scrip

Executive Summary

The General Court of the European Union has upheld the European Medicines Agency's decision to deny Nycomed a waiver for a paediatric investigation plan (PIP) for its imaging agent perflubutane. The ruling appears to mean that the agency can oblige firms seeking new marketing authorisations for medicines, preventative products and diagnostics to perform paediatric research into indications that they had not intended to develop. Securing a waiver for a PIP also looks set to become more difficult, said Mauro Turrini, from the law firm Bird & Bird.

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