New Regulatory Framework for Medical Devices in Japan: Current Regulatory Considerations Regarding Clinical Studies
- 13 March 2018
- journal article
- research article
- Published by Elsevier BV in Journal of Vascular and Interventional Radiology
- Vol. 29 (5), 657-660
- https://doi.org/10.1016/j.jvir.2017.12.022
Abstract
No abstract availableKeywords
This publication has 14 references indexed in Scilit:
- Rapid Globalization of Medical Device Clinical Development Programs in Japan ― The Case of Drug-Eluting Stents ―Circulation Journal, 2018
- An FDA Viewpoint on Unique Considerations for Medical-Device Clinical TrialsThe New England Journal of Medicine, 2017
- The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United StatesTherapeutic Innovation & Regulatory Science, 2017
- Real-World Evidence — What Is It and What Can It Tell Us?The New England Journal of Medicine, 2016
- Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in JapanJACC: Cardiovascular Interventions, 2016
- The 21st Century Cures ActThe New England Journal of Medicine, 2015
- The 21st Century Cures Act — Will It Take Us Back in Time?The New England Journal of Medicine, 2015
- Pharmacoepidemiology in Japan: medical databases and research achievementsJournal of Pharmaceutical Health Care and Sciences, 2015
- The Randomized Registry Trial — The Next Disruptive Technology in Clinical Research?The New England Journal of Medicine, 2013
- From Randomized Controlled Trials to Observational StudiesAmerican Journal Of Medicine, 2009