Navigating the FDA Regulatory Processes

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.