FDA Clearance: An Integrated Clinical, Engineering, and Business Approach
Yitzhak Rosen (Superior NanoBioSystems, Silver Spring, Maryland, USA),Pablo Gurman (Argonne National Laboratory, Lemont, IL, USA),Noel Elman (Cambridge, Massachusetts, USA)
FDA Clearance: An Integrated Clinical, Engineering, and Business Approach
Yitzhak Rosen (Superior NanoBioSystems, Silver Spring, Maryland, USA),Pablo Gurman (Argonne National Laboratory, Lemont, IL, USA),Noel Elman (Cambridge, Massachusetts, 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.
Order online and we’ll ship when available
Our stock data is updated periodically, and availability may change throughout the day for in-demand items. Please call the relevant shop for the most current stock information. Prices are subject to change without notice.
Sign in or become a Readings Member to add this title to a wishlist.