Supporting Japan Applications With U.S. Data Is Slower, But Worth It – AGA
This article was originally published in The Gray Sheet
Executive Summary
AGA Medical will support its second regulatory application in Japan with U.S. data - despite the Japanese health ministry's preference for domestic data - because Japanese trials are prohibitively expensive, according to CEO Franck Gougeon
You may also be interested in...
Cardiac Science Aims To Recoup Japan Losses With Biphasic AEDs
Cardiac Science expects to regain share of the Japanese automatic external defibrillator market with the launch of its biphasic AEDs in Japan, according to CEO Raymond Cohen
Cardiac Science Aims To Recoup Japan Losses With Biphasic AEDs
Cardiac Science expects to regain share of the Japanese automatic external defibrillator market with the launch of its biphasic AEDs in Japan, according to CEO Raymond Cohen
Japan’s Rejection Of Foreign Trial Data Continues To Harry Newcomers
Small and mid-size device companies seeking product approval in Japan will encounter resistance to international trial data, according to Pacific Bridge Medical (PBM) President Ames Gross