Pediatric Clinical Trials
Over the past decades, drugs have been used in children at different ages, outside the terms of their marketing authorizations in relation to indication, dosage, age, and route of administration, both in Europe and worldwide. The off-label use of drugs exposes children to unexpected adverse reactions or to suboptimal treatment. To develop safe medicines for children, ensuring that pediatric medicines are of high quality, ethically researched, and authorized appropriately, many legislative efforts have been made at European and international level. This chapter will address specific regulatory and ethical aspects included in legal frameworks and ethical guidelines.
KeywordsEuropean Union Legal Representative Orphan Medicinal Product Market Exclusivity Pediatric Clinical Trial
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