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New Visualization Models of Designation Pathway and Group Categorization of Device-Drug and Device-Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions.
Uemura, Nobuo; Kasanuki, Hiroshi; Umezu, Mitsuo.
Affiliation
  • Uemura N; Joint Graduate School of Tokyo Women's Medical University and Waseda University (TWIns), Cooperative Major in Advanced Biomedical Sciences, Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan. nobuouemura@akane.waseda.jp.
  • Kasanuki H; Joint Graduate School of Tokyo Women's Medical University and Waseda University (TWIns), Cooperative Major in Advanced Biomedical Sciences, Graduate School of Advanced Science and Engineering, Waseda University, c/o UMEZU Lab, 2-2 Wakamatsucho, Shinjukuku, Tokyo, 162-480, Japan. nobuouemura@akane.wa
  • Umezu M; Waseda Institute for Medical Regulatory Science, Waseda University, Tokyo, Japan.
Ther Innov Regul Sci ; 55(4): 807-817, 2021 07.
Article in En | MEDLINE | ID: mdl-33844189
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biological Products / Pharmaceutical Preparations Type of study: Prognostic_studies Country/Region as subject: America do norte Language: En Journal: Ther Innov Regul Sci Year: 2021 Document type: Article Affiliation country: Japan Country of publication: Switzerland
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biological Products / Pharmaceutical Preparations Type of study: Prognostic_studies Country/Region as subject: America do norte Language: En Journal: Ther Innov Regul Sci Year: 2021 Document type: Article Affiliation country: Japan Country of publication: Switzerland