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books
| book details |
Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach
Edited by Yitzhak Rosen, Edited by Pablo Gurman, Edited by Noel Elman
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| on special |
normal price: R 5 573.95
Price: R 5 015.95
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| book description |
This book provides a unique knowledge source of the FDA’s regulatory processes to anyone interested in the development and approval of biomedical products. Navigating the FDA Regulatory Processes will be of particular importance for those innovating in biomedical devices, pharmacological therapies, and combination products, who are interested in considering regulatory affairs early on in product development. The authors offer a comprehensive exploration of FDA regulations, providing industry insights and guidance for navigating the complexities of drug and device development. The book offers concrete examples, industry perspectives, and historical context, ensuring clarity and aiding in successful understanding of the requirements for regulatory compliance. Readers will also gain a thorough understanding of FDA regulatory processes, from securing approvals to navigating expedited pathways. Lastly, the book provides unique insights into the FDA approach for emergency preparedness, including discussing the recent COVID-19 pandemic. Biomedical industry personnel, engineers, scientists, entrepreneurs, medical doctors, students, and anyone interested in the development and approval of medical products in the US will find this book useful and essential.
| product details |
Normally shipped |
Publisher | Taylor & Francis Inc
Published date | 31 Jan 2025
Language |
Format | Hardback
Pages | 252
Dimensions | 234 x 156 x 0mm (L x W x H)
Weight | 640g
ISBN | 978-1-4822-0708-8
Readership Age |
BISAC | science / biotechnology
| other options |
Normally shipped |
Readership Age |
Normal Price | R 6 660.95
Price | R 5 994.95
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An epic love story with the pulse of a thriller that asks: what would you risk for a second chance at first love?
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Matt Dinniman
Paperback / softback
480 pages
was: R 522.95
now: R 459.95
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