Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan()

BACKGROUND: Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. METHODS: To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of c...

Descripción completa

Detalles Bibliográficos
Autores principales: Handa, Nobuhiro, Ishii, Kensuke, Matsui, Yutaka, Ando, Yuki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2015
Materias:
Research Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4588369/
https://www.ncbi.nlm.nih.gov/pubmed/26501120
http://dx.doi.org/10.1016/j.ebiom.2015.07.011

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4588369/
https://www.ncbi.nlm.nih.gov/pubmed/26501120
http://dx.doi.org/10.1016/j.ebiom.2015.07.011

Ejemplares similares