| Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach Contributor(s): Rosen, Yitzhak (Author), Gurman, Pablo (Author), Elman, Noel (Author) |
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ISBN: 1482207087 ISBN-13: 9781482207088 Publisher: CRC Press OUR PRICE: $132.95 Product Type: Hardcover - Other Formats Published: January 2025 This item may be ordered no more than 25 days prior to its publication date of January 1, 2025 |
| Additional Information |
| BISAC Categories: - Medical | Biotechnology - Medical | Pharmacology - Technology & Engineering | Biomedical |
| Dewey: 615 |
| Physical Information: 400 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: 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. |