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Full 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.
Contents
Chapter 1- Introduction
Pablo Gurman, Yitzhak Rosen, and Noel M. Elman
Chapter 2- Dancing with the FDA: Managing Expectations
Raymond Vennare
Chapter 3- New Drug Application
Harvey M. Arbit and Wrenda Teeple
Chapter 4- Basics of Generic Drug Regulation
Giridhar Prasad and Anurag Patel
Chapter 5- Introduction to Medical Device Regulation
Anurag Patel
Chapter 6- FDA and Regulation of Biologics
Oliver V. Cácananta
Chapter 7- Combination Products
Evan B. Siegel
Chapter 8- FDA Expedited Pathways
Oliver V. Cácananta
Chapter 9- Investigator-Initiated Sponsored Research
Harvey M. Arbit and Wrenda Teeple
Chapter 10- Medical Countermeasures for Public Health Emergency Preparedness and Response in The United States: A Regulatory Perspective
Angela Bellos, Jack Russell, and Doris Snow
