Characteristics and Changes of Pediatric Therapeutic Trials under the Best Pharmaceuticals for Children Act.

Avant, Debbie; Wharton, Gerold T; Murphy, Dianne

Avant, Debbie; Wharton, Gerold T; Murphy, Dianne.

Afiliación

Avant D; Offices of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD. Electronic address: Debbie.Avant@fda.hhs.gov.
Wharton GT; Offices of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.
Murphy D; Offices of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.

J Pediatr ; 192: 8-12, 2018 01.

Article en En | MEDLINE | ID: mdl-29029810

Asunto(s)

Desarrollo de Medicamentos; United States Food and Drug Administration; Niño; Etiquetado de Medicamentos; Humanos

Palabras clave

FDA; Pediatric clinical trials; pediatric drug development; pediatric labeling

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Desarrollo de Medicamentos Tipo de estudio: Prognostic_studies Límite: Child / Humans Idioma: En Revista: J Pediatr Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos

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