The General Court of the European Union (formerly the EU Court of First Instance) has upheld a European Medicines Agency decision to deny Nycomed a waiver for a paediatric investigation plan (PIP) for its ultrasound echocardiographic imaging agent perflubutane1.
The ruling suggests that the EMA 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...
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