Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan.

Gomes, Kelly Lucy Guimarães; da Silva, Ricardo Eccard; da Silva, João Batista; Bosio, Cleila Guimarães Pimenta; Novaes, Maria Rita Carvalho Garbi

Gomes, Kelly Lucy Guimarães; da Silva, Ricardo Eccard; da Silva, João Batista; Bosio, Cleila Guimarães Pimenta; Novaes, Maria Rita Carvalho Garbi.

Afiliación

Gomes KLG; Brazilian Health Regulatory Agency (Anvisa), Brasília, Brazil; Faculty of Health Sciences, University of Brasília (UnB), Brasília, Brazil. Electronic address: klggomes2@gmail.com.
da Silva RE; Brazilian Health Regulatory Agency (Anvisa), Brasília, Brazil.
da Silva JB; Brazilian Health Regulatory Agency (Anvisa), Brasília, Brazil; Faculty of Health Sciences, University of Brasília (UnB), Brasília, Brazil.
Bosio CGP; Faculty of Health Sciences, University of Brasília (UnB), Brasília, Brazil.
Novaes MRCG; Faculty of Health Sciences, University of Brasília (UnB), Brasília, Brazil.

Cytotherapy ; 25(10): 1113-1123, 2023 10.

Article en En | MEDLINE | ID: mdl-37436339

Asunto(s)

Productos Biológicos; Mercadotecnía; Humanos; Productos Biológicos/efectos adversos; Brasil; Unión Europea; Japón; Preparaciones Farmacéuticas; Estados Unidos

Palabras clave

advanced cell therapy; drug monitoring; gene therapy; regulatory framework; tissue engineering

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Mercadotecnía Tipo de estudio: Guideline / Screening_studies Límite: Humans País/Región como asunto: America do norte / America do sul / Asia / Brasil Idioma: En Revista: Cytotherapy Asunto de la revista: TERAPEUTICA Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido

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