Book Detail
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Medicine > Pharmacology
FDA Clearance: An Integrated Clinical, Engineering, and Business Approach
Rosen, Yitzhak
ISBN 13: 
9781482207088
ISBN 10: 
1482207087
Category: 
Pharmacology
Edition: 
1
Publisher: 
Taylor & Francis
Publication Date: 
01/2021
Format: 
Cloth
Status: 
Not Yet Published
Imprint: 
CRC Press
Affiliation: 
Superior NanoBioSystems, Silver Spring, Maryland, USA
Pages: 
400
Weight: 
2
Retail Price: 
139.95 (Tentative Price May Change)
Quantity On Hand: 
0
Quantity On Order: 
0
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Synopsis:

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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