This book provides a unique knowledge source of the FDAs 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.
PART 1: Overview. Introduction: Overview of the FDA. PART 2: Clinical Considerations. Understanding Clinical Trials for Drugs and Devices with Case studies. Designing Clinical Trials for FDA. Simplifying the process of FDA submission and clearance. Interacting with the FDA. Recalls and Failures. Patient Safety and Satisfaction. PART 3: Technological Considerations. FDA and other regulatory requirements. PART 4: Industry and Business Considerations. Capital Challenges. Technology Transition [ Dolphin Consulting Group. Business Transformations for FDA Clearance. PART 5 Appendix and FDA Reference for Cleared Biomedical and Biomaterials. Appendix and FDA Reference.
Dr. Pablo Gurman, MD, MSM, received his MD from Buenos Aires University School of Medicine and a masters 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. Elmans research and development focus is on rapid translation from idea conceptualization to product realization. He holds bachelors and masters 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.
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