1st Edition

Navigating the FDA Regulatory Processes An Integrated Clinical and Engineering Approach

By Yitzhak Rosen, Pablo Gurman, Noel Elman Copyright 2024
    296 Pages 3 B/W Illustrations
    by CRC Press

    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.

    PART 1: Overview

    Introduction: Overview of the FDA, [Dr. Gurman, Dr. Rosen, Dr. Elman]

    PART 2: Clinical Considerations

    Understanding Clinical Trials for Drugs and Devices with Case studies [Dr. Gurman]

    Designing Clinical Trials for FDA [Clinical Trials Consulting Group TBD]

    Simplifying the process of FDA submission and clearance

    Interacting with the FDA [FDA consulting group, TBD]

    Recalls and Failures

    Patient Safety and Satisfaction [Dr. Ronen Rozenblum et al, Unit of Patient Satisfaction, Safety, Brigham Women’s Hospital, Harvard Medical School)

    PART 3: Technological Considerations

    FDA and other regulatory requirements [Dr. Willie Foerstener et al, Medical Device Consultant]

    PART 4: Industry and Business Considerations

    Capital Challenges

    Technology Transition [Dolphin Consulting Group, Dr. Steve Jarret]

    Business Transformations for FDA Clearance

    PART 5: Appendix and FDA Reference for Cleared Biomedical and Biomaterials

    Appendix and FDA Reference (Dr. Gurman)


    Dr. Yitzhak Rosen, MD, is a graduate of the Tel Aviv University of Medicine. He is currently working in the Cardiology Department at SUNY Downstate Medical Center. He was previously a visiting research scientist at the Institute for Soldier Nanotechnologies, Massachusetts Institute of Technology. He is also the president and CEO of Superior NanoBioSystems LLC, a biomedical company. He has served in the Israel Defense Forces (IDF) as a medical officer and physician in militarily active areas. He completed a medical internship at the Rabin Medical Center and has worked at the Oncology Institutes of both the Rabin and the Sheba Medical Centers in Israel. He has invented a microfluidic chip platform, funded by the Defense Advanced Research Projects Agency (DARPA), for effecting extremely rapid blood typing and cross-matching for mass casualties in collaboration with the MEMS and Nanotechnology Exchange. In addition, he is the inventor of several medical ultrasound technologies.

    Dr. Pablo Gurman received his MD from Buenos Aires University School of Medicine in 2002, where he worked at the Pharmacology Department for 10 years. Dr. Gurman is currently the Chief Medical Officer of GearJump Technologies, a biotechnology company dedicated to develop innovative solutions to public health problems. Prior to this appointment, Dr. Gurman was a research scientist at the Materials Science and Engineering Department at the University of Texas-Dallas, as well as research collaborator at Dr. Elman’s group at the Institute for Soldiers Nanotechnologies at the Massachusetts Institute of Technology (MIT). Dr. Gurman was a visiting scientist at Argonne National Laboratory, where he worked under the artificial retina program. Dr. Gurman’s primary research interests involves micro and nanotechnology for medical diagnostics and therapeutics, controlled release technologies and biomaterials.

    Noel M. Elman, PhD, is the CEO and founder of GearJump Technologies,  LLC, a company dedicated to development of biotechnological solutions for public health applications. Dr. Elman is also a lecturer in technology and innovation at the Buenos Aires Institute of Technology.  He worked at Draper Laboratory, an MIT-affiliated DoD-supported R&D center, where he was an appointed distinguished member of the technical staff.  Prior to this appointment, he was a research scientist and principal investigator at the Institute for Soldier Nanotechnologies at MIT, leading a translational research group focused on developing technologies for biotech, biomed, and public health applications.  In addition, he was appointed an Innovation Fellow at Massachusetts General Hospital.  Dr. Elman’s research focus is on rapid translation from idea conceptualization to experimental realization. He earned his bachelor’s and master’s degrees in electrical engineering at Cornell University, and his PhD degree in electrical engineering at Tel Aviv University. He performed postdoctoral studies at MIT, investigating several micro- and nanodevices for therapeutics and diagnostics.