| ISBN13: | 9781482207088 |
| ISBN10: | 1482207087 |
| Binding: | Hardback |
| No. of pages: | 296 pages |
| Size: | 234x156 mm |
| Language: | English |
| Illustrations: | 3 Illustrations, black & white; 3 Line drawings, black & white; 20 Tables, black & white |
| 700 |
Navigating the FDA Regulatory Processes
GBP 89.00
Click here to subscribe.
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 book provides a unique knowledge source of FDA's regulatory processes to anyone interested in 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, 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. It 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 the recent COVID-19 pandemic.
Biomedical industry personnel, engineers, scientists, entrepreneurs, medical doctors, students and anyone interested in development and approval of medical products in the US will find this book useful and essential.
Chapter 1- Introduction
Chapter 2- Dancing with the FDA: Managing Expectations
Chapter 3- New Drug Application
Chapter 4- Basics of Generic Drug Regulation
Chapter 5- Introduction to Medical Device Regulation
Chapter 6- FDA and Regulation of Biologics
Chapter 7- Combination Products
Chapter 8- FDA Expedited Pathways
Chapter 9- Investigator-Initiated Sponsored Research
Chapter 10- Medical Countermeasures for Public Health Emergency Preparedness and Response in The United States: A Regulatory Perspective