Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.

Reaman, Gregory; Karres, Dominik; Ligas, Franca; Lesa, Giovanni; Casey, Denise; Ehrlich, Lori; Norga, Koen; Pazdur, Richard

Reaman, Gregory; Karres, Dominik; Ligas, Franca; Lesa, Giovanni; Casey, Denise; Ehrlich, Lori; Norga, Koen; Pazdur, Richard.

Afiliação

Reaman G; Oncology Center of Excellence, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.
Karres D; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Ligas F; Paediatric Medicines Office, Scientific Evidence Generation Department, Human Medicines Division, European Medicines Agency, Amsterdam, the Netherlands.
Lesa G; Paediatric Medicines Office, Scientific Evidence Generation Department, Human Medicines Division, European Medicines Agency, Amsterdam, the Netherlands.
Casey D; Paediatric Medicines Office, Scientific Evidence Generation Department, Human Medicines Division, European Medicines Agency, Amsterdam, the Netherlands.
Ehrlich L; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Norga K; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Pazdur R; Federal Agency for Medicines and Health Products and Paediatric Oncology, Antwerp University Hospital, Edegem, Belgium.

J Clin Oncol ; 38(36): 4227-4230, 2020 12 20.

Article em En | MEDLINE | ID: mdl-32946356

Assuntos

Desenvolvimento de Medicamentos/organização & administração; Indústria Farmacêutica/organização & administração; Europa (Continente); Feminino; Humanos; Masculino; Estados Unidos; United States Food and Drug Administration

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Indústria Farmacêutica / Desenvolvimento de Medicamentos Limite: Female / Humans / Male País/Região como assunto: America do norte / Europa Idioma: En Revista: J Clin Oncol Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Moldávia

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