Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach
Editat de Yitzhak Rosen, Pablo Gurman, Noel Elmanen Limba Engleză Hardback – 29 noi 2024
"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.
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Specificații
ISBN-13: 9781482207088
ISBN-10: 1482207087
Pagini: 296
Ilustrații: 6
Dimensiuni: 156 x 234 mm
Ediția:1
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States
ISBN-10: 1482207087
Pagini: 296
Ilustrații: 6
Dimensiuni: 156 x 234 mm
Ediția:1
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States
Public țintă
Academic and Professional Practice & DevelopmentCuprins
Chapter 1- Introduction
Chapter 2- Dancing with the FDA: Managing Expectations
Chapter 3- New Drug Application
Chapter 4- Basics of Generic Drug Regulation
Chapter 5- Introduction to Medical Device Regulation
Chapter 6- FDA and Regulation of Biologics
Chapter 7- Combination Products
Chapter 8- FDA Expedited Pathways
Chapter 9- Investigator-Initiated Sponsored Research
Chapter 10- Medical Countermeasures for Public Health Emergency Preparedness and Response in The United States: A Regulatory Perspective
Chapter 2- Dancing with the FDA: Managing Expectations
Chapter 3- New Drug Application
Chapter 4- Basics of Generic Drug Regulation
Chapter 5- Introduction to Medical Device Regulation
Chapter 6- FDA and Regulation of Biologics
Chapter 7- Combination Products
Chapter 8- FDA Expedited Pathways
Chapter 9- Investigator-Initiated Sponsored Research
Chapter 10- Medical Countermeasures for Public Health Emergency Preparedness and Response in The United States: A Regulatory Perspective
Notă biografică
Dr. Pablo Gurman, MD, MSM, holds a Doctor of Medicine (MD) degree 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, graduated from the Tel Aviv University Faculty of Medicine. He worked in the Cardiology Department at SUNY Downstate Medical Center 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 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 specializes in rapid translation from concept to experimental 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.
Dr. Yitzhak Rosen, MD, graduated from the Tel Aviv University Faculty of Medicine. He worked in the Cardiology Department at SUNY Downstate Medical Center 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 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 specializes in rapid translation from concept to experimental 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.
Descriere
This book provides a comprehensive overview of FDA (Federal Drug Administration) procedures. It simplifies the complexities involved in getting FDA clearance by using an integrated approach of clinical, engineering, and business aspects. It includes both medical devices and drug development.