A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials

• Autori principali: Klaus Rose (Autore), Hans Kummer (Autore)
• Natura: Libro
• Pubblicazione: MDPI AG, 2015-05-01T00:00:00Z.
• Soggetti: article
• Accesso online: Connect to this object online.

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusi...