FDA Clearance: An Integrated Clinical, Engineering, and Business Approach (Hardcover)

FDA Clearance: An Integrated Clinical, Engineering, and Business Approach By Yitzhak Rosen, Pablo Gurman, Noel Elman Cover Image

FDA Clearance: An Integrated Clinical, Engineering, and Business Approach (Hardcover)

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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.

Product Details ISBN: 9781482207088
ISBN-10: 1482207087
Publisher: CRC Press
Publication Date: December 31st, 2023
Pages: 400
Language: English