Shin Iwamoto, Kenneth Cavanaugh, Misti Malone, Aaron Lottes, Robert Thatcher, Katherine Kumar, Steve Rowland, Neal Fearnot, Takahiro Uchida, Chie Iwaishi, Kazuhisa Senshu, Ryo Konishi, Koji Ikeda, Yuka Suzuki, Fumiaki Ikeno, Atsushi Tamura, Mami Ho, Moe Ohashi, Hiroshi Katayama, Mitchell W Krucoff
As medical device development becomes increasingly global, the opportunities and potential advantages offered by international clinical trial and regulatory approval strategies are also growing. In particular, medical device clinical trials involving sites in both the United States and Japan and intended to support marketing in both countries may warrant particular consideration, given the similarities in their regulatory systems, patients and clinical practice patterns, and market sizes. Since 2003, the US-Japan Harmonization By Doing (HBD) initiative has been focused on identifying and addressing clinical and regulatory barriers to medical devices access in both countries via collaboration between governmental, academic, and industry stakeholders...
February 24, 2023: Cardiovascular Revascularization Medicine: Including Molecular Interventions