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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...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Elsevier
2015
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| Materias: | |
| 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 |