Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States.

Penkov, Dobromir; Tomasi, Paolo; Eichler, Irmgard; Murphy, Dianne; Yao, Lynne P; Temeck, Jean

Penkov, Dobromir; Tomasi, Paolo; Eichler, Irmgard; Murphy, Dianne; Yao, Lynne P; Temeck, Jean.

Afiliação

Penkov D; European Medicines Agency, London, United Kingdom.
Tomasi P; European Medicines Agency, London, United Kingdom.
Eichler I; European Medicines Agency, London, United Kingdom.
Murphy D; Food and Drug Administration, Silver Spring, MD, USA.
Yao LP; Food and Drug Administration, Silver Spring, MD, USA.
Temeck J; Food and Drug Administration, Silver Spring, MD, USA.

Ther Innov Regul Sci ; 51(3): 360-371, 2017 May 01.

Article em En | MEDLINE | ID: mdl-28674673

Palavras-chave

Best Pharmaceuticals for Children Act (BPCA); EU Paediatric Regulation; Paediatric Committee; Pediatric Research Equity Act (PREA); Pediatric Review Committee (PeRC)

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Guideline Idioma: En Revista: Ther Innov Regul Sci Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Reino Unido

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