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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, Shin; Cavanaugh, Kenneth; Malone, Misti; Lottes, Aaron; Thatcher, Robert; Kumar, Katherine; Rowland, Steve; Fearnot, Neal; Uchida, Takahiro; Iwaishi, Chie; Senshu, Kazuhisa; Konishi, Ryo; Ikeda, Koji; Suzuki, Yuka; Ikeno, Fumiaki; Tamura, Atsushi; Ho, Mami; Ohashi, Moe; Katayama, Hiroshi; Krucoff, Mitchell W.
Affiliation
  • Iwamoto S; Office of Medical Devices Policy, Policy Planning Division for Pharmaceutical Industry Promotion and Medical Information Management, Health Policy Bureau, Ministry of Health, Labour, and Welfare, Chiyoda-ku, Tokyo 100-8916, Japan. Electronic address: iwamoto-shin.55h@mhlw.go.jp.
  • Cavanaugh K; Office of Health Technology II: Cardiovascular Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: kenneth.cavanaugh@fda.hhs.gov.
  • Malone M; Office of Health Technology II: Cardiovascular Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: misti.malone@fda.hhs.gov.
  • Lottes A; Weldon School of Biomedical Engineering, Purdue University, West Lafayette, Indiana 47906, USA. Electronic address: lottes@purdue.edu.
  • Thatcher R; Diaxamed, 200C Patewood Dr. Suite 4125, Greenville, SC 29615, USA. Electronic address: robertthatcher@diaxamed.com.
  • Kumar K; 4C Medical Technologies, Inc., 6655 Wedgwood Rd N., Suite 160, Maple Grove, MN 55311, USA. Electronic address: kkumar@4CMed.com.
  • Rowland S; OrbusNeich Medical Trading Inc., 5363 NW 35th Avenue, Fort Lauderdale, FL 33309, USA. Electronic address: srowland@orbusneich.com.
  • Fearnot N; Cook Advanced Technologies, 1400 Cumberland Avenue, West Lafayette, IN 47906, USA. Electronic address: nfearnot@medinstitute.com.
  • Uchida T; JOMDD, Inc., Nihonbashi-Honcho #601, Chuo-Ku, Tokyo 103-0023, Japan.
  • Iwaishi C; Edwards Lifesciences, One Edwards Way, Irvine, CA 92614, USA. Electronic address: chie_iwaishi@edwards.com.
  • Senshu K; Terumo Corporation, Shinjuku-ku, Tokyo 163-1450, Japan. Electronic address: kazuhisa_senshu@terumo.co.jp.
  • Konishi R; Terumo Corporation, Shinjuku-ku, Tokyo 163-1450, Japan. Electronic address: Ryo_Konishi@terumo.co.jp.
  • Ikeda K; Department of Development Promotion, Clinical Research, Innovation and Education Center, Tohoku University Hospital (CRIETO), Sendai, Miyagi 980-8574, Japan. Electronic address: koji-ike3@hosp.tohoku.ac.jp.
  • Suzuki Y; Department of International Affairs, Clinical Research, Innovation and Education Center, Tohoku University Hospital (CRIETO), Sendai, Miyagi 980-8574, Japan. Electronic address: suzuki-yuka@hosp.tohoku.ac.jp.
  • Ikeno F; Stanford Byers Center for Biodesign, Stanford University, Stanford, CA 94305, USA. Electronic address: fikeno@stanford.edu.
  • Tamura A; Clinical Research Center in Hiroshima, Hiroshima University Hospital, Minami-ku, Hiroshima 734-8551, Japan. Electronic address: papatam@hiroshima-u.ac.jp.
  • Ho M; Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Tokyo 100-0013, Japan. Electronic address: ho-mami@pmda.go.jp.
  • Ohashi M; Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Tokyo 100-0013, Japan. Electronic address: ohashi-moe@pmda.go.jp.
  • Katayama H; Research Management Division, Clinical Research Support Office, National Cancer Center Hospital, Chuo-ku, Tokyo 104-0045, Japan. Electronic address: hirkatay@ncc.go.jp.
  • Krucoff MW; Duke University Medical Center/Duke Clinical Research Institute, P.O. Box 17969, Durham, NC 27715, USA. Electronic address: Mitchell.krucoff@duke.edu.
Cardiovasc Revasc Med ; 52: 67-74, 2023 07.
Article in En | MEDLINE | ID: mdl-36870799
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Device Approval Type of study: Prognostic_studies Limits: Humans Country/Region as subject: America do norte / Asia Language: En Journal: Cardiovasc Revasc Med Journal subject: ANGIOLOGIA / CARDIOLOGIA Year: 2023 Document type: Article Country of publication:
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Device Approval Type of study: Prognostic_studies Limits: Humans Country/Region as subject: America do norte / Asia Language: En Journal: Cardiovasc Revasc Med Journal subject: ANGIOLOGIA / CARDIOLOGIA Year: 2023 Document type: Article Country of publication: