FDA Clearance: An Integrated Clinical, Engineering, and Business Approach

Yitzhak Rosen, Pablo Gurman, Noel Elman

Anno: 2018
Rilegatura: Hardback
Pagine: 400 p.
Testo in English
Dimensioni: 235 x 156 mm
  • EAN: 9781482207088
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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.