ISEKI Hiroshi
   Department   Research Institutes and Facilities, Research Institutes and Facilities
   Position  
Article types Original article
Language English
Peer review Peer reviewed
Title Analysis of Benefit-risk Balance in Decision-making of the Food and Drug Administration for Premarket Approval of Therapeutic Medical Devices.
Journal Formal name:Advanced Biomedical Engineering
ISSN code:21875219
Domestic / ForeginForegin
Volume, Issue, Page 2,pp.101-106
Author and coauthor MURAGAKI Yoshihiro†, UEMATSU Miyuki, ISEKI Hiroshi, UMEZU Mitsuo
Publication date 2014/01
Summary Released dates
Released: January 24, 2014 [Advance Publication] Released: - Received: July 26, 2013 Revised: October 20, 2013 Accepted: November 07, 2013

Keywords : premarket approval, benefit-risk balance, decision-making, regulatory science.
DOI 10.14326/abe.2.101
PMID 2015213494