A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration.

Rohr, Ulrich-P; Iovino, Mario; Rudofsky, Leonie; Li, Qiyu; Juritz, Stephanie; Gircys, Arunas; Wildner, Oliver; Bujar, Magda; Bolte, Claus; Dalla Torre di Sanguinetto, Simon; Wolfer, Anita

Rohr, Ulrich-P; Iovino, Mario; Rudofsky, Leonie; Li, Qiyu; Juritz, Stephanie; Gircys, Arunas; Wildner, Oliver; Bujar, Magda; Bolte, Claus; Dalla Torre di Sanguinetto, Simon; Wolfer, Anita.

Afiliação

Rohr UP; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Iovino M; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Rudofsky L; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Li Q; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Juritz S; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Gircys A; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Wildner O; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Bujar M; Centre for Innovation in Regulatory Science (CIRS), London, UK.
Bolte C; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Dalla Torre di Sanguinetto S; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.
Wolfer A; Division Clinical Assessment, Authorization Sector Swiss Agency for Therapeutic Products, Swissmedic, Bern, Switzerland.

Clin Transl Sci ; 16(9): 1569-1581, 2023 09.

Article em En | MEDLINE | ID: mdl-37408165

Assuntos

Aprovação de Drogas; Estados Unidos; Humanos; United States Food and Drug Administration; Incerteza; Europa (Continente)

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aprovação de Drogas Tipo de estudo: Prognostic_studies Limite: Humans País/Região como assunto: America do norte / Europa Idioma: En Revista: Clin Transl Sci Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Suíça

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