EMA Reviews Experience With Deferring PIPs: Will it Result In Earlier Pediatric Trials?
The European Medicines Agency is examining its current experience with granting deferrals for studies mandated under the EU Paediatric Regulation, and is re-considering when it is most appropriate to grant deferrals for neonatal studies.
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Weeks before an important report is due on the impact of the EU Paediatric Regulation, a senior European Commission official shares his personal reflections on how some simple concepts in the legislation have not translated into the real world as intended.
As the European Medicines Agency starts to address the findings of a report that questions the wisdom of granting lengthy deferrals for neonatal studies, an industry expert warns that by requiring such studies to be initiated earlier, the agency may come into conflict with ethics committees.
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