Navigating the FDA regulatory processes : an integrated clinical and engineering approach

• Material Type: 図書
• ISBN: 9781482207088 hardcover; 1482207087 hardcover
• Title: Navigating the FDA regulatory processes : an integrated clinical and engineering approach
• Author/Editor: edited by Pablo Gurman, Yitzhak Rosen, and Noel M. Elman
• Edition: First edition
• Author Heading: Rosen, Yitzhak; Gurman, Pablo; Elman, Noel
• Publication, Distribution, etc.: Boca Raton, FL : CRC Press (出版)
• Publication Date: 2025; 著作権日付 : ©2025
• Publication Date (W3CDTF): 2025
• Extent: ix, 251 pages
• Size: 24 cm
• Place of Publication (Country Code): US
• Text Language Code: eng
• Content Type: text
• Media Type: unmediated
• Carrier Type: volume
• Subject Heading: United States Food and Drug Administration; Public health--Equipment and supplies--Standards--United States
• LCC: RA445
• NDLC: EG215
• Target Audience: 一般
• Note (Target Audience): Biomedical industry personnel, engineers, scientists, entrepreneurs, medical doctors, students, and anyone interested in the development and approval of medical products in the US will find this book useful and essential
• Note (Bibliography): Includes bibliographical references and index
• Holding library: 国立国会図書館
• Call No.: EG215-D41
• Data Provider (Database): 国立国会図書館 : 国立国会図書館蔵書; https://ndlsearch.ndl.go.jp
• Bibliographic ID (NDL): 025575324; http://id.ndl.go.jp/bib/025575324
• OCLC No.: 1525196310; https://www.worldcat.org/oclc/1525196310
• Cataloging Rule: RDA
• Bibliographic Record Category (NDL): 211

• Contents: Chapter 1. Introduction / Pablo Gurman, Yitzhak Rosen, Noel M. ElmanChapter 2. Dancing with the FDA: managing expectations / Raymond VennareChapter 3....
• Summary, etc.: Navigating the FDA Regulatory Processes will be of particular importance for those innovating in biomedical devices, pharmacological therapies, and co...