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Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct.
Iwamoto S, Cavanaugh K, Malone M, Lottes A, Thatcher R, Kumar K, Rowland S, Fearnot N, Uchida T, Iwaishi C, Senshu K, Konishi R, Ikeda K, Suzuki Y, Ikeno F, Tamura A, Ho M, Ohashi M, Katayama H, Krucoff MW. Iwamoto S, et al. Among authors: iwaishi c. Cardiovasc Revasc Med. 2023 Jul;52:67-74. doi: 10.1016/j.carrev.2023.02.015. Epub 2023 Feb 24. Cardiovasc Revasc Med. 2023. PMID: 36870799