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Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach
Yitzhak Rosen
(Autor)
·
Noel Elman
(Autor)
·
Pablo Gurman
(Autor)
·
CRC Press
· Tapa Dura
Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach - Rosen, Yitzhak ; Gurman, Pablo ; Elman, Noel
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Reseña del libro "Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach"
This book provides a comprehensive overview of FDA (Federal Drug Administration) procedures. It simplifies the complexities involved in getting FDA clearance by using an integrated approach of clinical, engineering, and business aspects. It includes both medical devices and drug development. This involves understanding the structure of the FDA, its purpose, and its initiatives. This book also examines what is needed for designing clinical trials and addressing recalls and failures. It uses case studies to further illustrate the integrated method stressed throughout this work.
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