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...

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Bibliographic Details
Published in:EBioMedicine
Main Authors: Handa, Nobuhiro, Ishii, Kensuke, Matsui, Yutaka, Ando, Yuki
Format: Artigo
Language:Inglês
Published: Elsevier 2015
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Research Paper
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC4588369/
https://ncbi.nlm.nih.gov/pubmed/26501120
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.ebiom.2015.07.011
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