US Food and Drug Administration Facilitated Pediatric Approval Programs: Application to Pediatric Neurological Disorders.

Cruz, Emily Da; Rahim, Faraan; Lemmon, Monica; Mikati, Mohamad A

Cruz, Emily Da; Rahim, Faraan; Lemmon, Monica; Mikati, Mohamad A.

Afiliação

Cruz ED; Division of Pediatric Neurology and Developmental Medicine, Department of Pediatrics, Duke University, Durham, NC, USA.
Rahim F; Division of Pediatric Neurology and Developmental Medicine, Department of Pediatrics, Duke University, Durham, NC, USA.
Lemmon M; Division of Pediatric Neurology and Developmental Medicine, Department of Pediatrics, Duke University, Durham, NC, USA.
Mikati MA; Division of Pediatric Neurology and Developmental Medicine, Department of Pediatrics, Duke University, Durham, NC, USA.

J Child Neurol ; 37(3): 222-231, 2022 03.

Article em En | MEDLINE | ID: mdl-35135372

Assuntos

Doenças do Sistema Nervoso; Neurologia; Criança; Aprovação de Drogas; Humanos; Doenças do Sistema Nervoso/tratamento farmacológico; Estados Unidos; United States Food and Drug Administration

Palavras-chave

Best Pharmaceuticals for Children Act; FDA; drug approval; pediatric drugs; pediatric research equity act; rare pediatric drug designation

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doenças do Sistema Nervoso / Neurologia Limite: Child / Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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