Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach

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.

Table of 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

About the Author :
Dr. Pablo Gurman, MD, MSM, received his MD from Buenos Aires University School of Medicine and a master’s degree in management from Babson College. His experience spans 15 years of experience in R&D in the biotech and the pharmaceutical industry, as well as more than 15 years of R&D in microsystems and nanotechnology working at MIT, The University of Texas at Dallas and Argonne National Laboratory (Artificial Retina Program). His primary interests include drug development, medical device development with focus on microsystems and nanotechnology, biotechnology and public health. Dr. Yitzhak Rosen, MD, is a graduate of Tel Aviv University of Medicine. He is a practicing physician. Dr. Rosen was affiliated with the Cardiology Department at SUNY Downstate Medical Center, New York and served as a visiting research scientist at the Institute for Soldier Nanotechnologies at MIT. Currently, he is the president and CEO of Superior NanoBioSystems LLC, a biomedical company. Dr. Rosen has also served as a medical officer and physician in militarily active areas with the Israel Defense Forces (IDF). He completed his medical internship at Rabin Medical Center and has worked at the Oncology Institutes of both Rabin and Sheba Medical Centers in Israel. Notably, he invented a microfluidic chip platform, funded by DARPA, for rapid blood typing and cross-matching in mass casualty situations, in collaboration with the MEMS and Nanotechnology Exchange. Additionally, he has developed several medical ultrasound technologies. Noel M. Elman, PhD, is the CEO and founder of GearJump Technologies, LLC, a company focused on creating biotechnological solutions for public health. He is also a faculty member at the Buenos Aires Institute of Technology. Previously, Dr. Elman worked at Draper Laboratory, an MIT-affiliated and DoD-supported R&D center, where he was a distinguished member of the technical staff. Before that, he served as a research scientist and principal investigator at the Institute for Soldier Nanotechnologies at MIT, leading a translational research group dedicated to developing biotech, biomedical, and public health technologies. Dr. Elman’s research and development focus is on rapid translation from idea conceptualization to product realization. He holds bachelor’s and master’s degrees in electrical engineering from Cornell University and a PhD in physical electronics from Tel Aviv University. Additionally, he completed postdoctoral studies at MIT, where he researched various micro- and nanodevices for therapeutics and diagnostics.