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Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach
Rosen, Yitzhak (Superior NanoBioSystems, Silver Spring, Maryland, USA)
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Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach
Rosen, Yitzhak (Superior NanoBioSystems, Silver Spring, Maryland, USA)
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.
400 pages, 60 black & white illustrations
Medie | Bøger Hardcover bog (Bog med hård ryg og stift omslag) |
Udkommer | 2025 |
ISBN13 | 9781482207088 |
Forlag | Taylor & Francis Inc |
Antal sider | 400 |
Mål | 632 g (Estimeret vægt) |
Sprog | Engelsk |