Regulating Pediatric Studies: An EU and US Perspective

Posted 05 June 2017 By Jennifer Sanguedolce, Narissa Mulchan

placeholder+image This article presents pediatric regulatory activities conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and highlights global harmonization efforts, collaborative discussions and regulations for pediatric clinical trials.

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Categories: Biologics and biotechnology, Drugs, Clinical, Features, US, Europe, FDA, EMA


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