title: The new European regulation on pediatric medicines: safety and ethics perspectives.
authors.forename: Antje
authors.initials: A
authors.lastname: Neubert
authors.forename: Claire
authors.initials: C
authors.lastname: Planner
authors.forename: Noel
authors.initials: N
authors.lastname: Cranswick
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D007880:Legislation, Drug / Q000941:ethics* / Q000639:trends*; D010372:Pediatrics / Q000941:ethics* / Q000331:legislation & jurisprudence*; D011785:Quality Assurance, Health Care