Navigating the FDA Regulatory Processes : An Integrated Clinical and Engineering Approach
Language: English
Published by Taylor & Francis Ltd (Sales) Jun 2026, 2026
- Softcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 95.53
Quantity: 2 available
Add to basketItem description from seller
Neuware - 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.…
Seller Inventory # 9781032904740
- Title
- Navigating the FDA Regulatory Processes : An Integrated Clinical and Engineering Approach
- Author
- Noel Elman
- Publisher
- Taylor & Francis Ltd (Sales) Jun 2026
- Publication year
- 2026
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 10
- 1032904747
- ISBN 13
- 9781032904740
- Item weight
- 372 grams
- Dimensions
- 234x156x14 mm
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.
"Synopsis" may belong to another edition of this title.
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.
"About the title" may belong to another edition of this title.
Shipping rates from Germany to U.S.A.
| Item | 7 to 10 business days | 5 to 7 business days |
|---|---|---|
| First item | £ 29.70 | £ 38.19 |
Payment methods
- Bank Wire Transfer
- Check
- Paypal
Store description
Das Unternehmen AHA-BUCH GmbH: Seit der Gründung von AHA-BUCH im Juli 2005 ist unser Hauptziel, zufriedenen Kunden so schnell und so preisgünstig wie möglich ihren Bücherwunsch zu erfüllen. Unsere Firma beschäftigt 16 Mitarbeiter, die nur ein Ziel kennen: den Kunden und seine Wünsche! Auf über 3700 m2 Fläche haben wir über 100.000 Bücher, Modernes Antiquariat und Spiele auf Lager.
Specialty
Kinderbücher & Kinderhör Casetten, German Books, Software, Natur & Tiere, Ratgeber, Sachbücher, Englische Bücher, Medizin & Gesundheit, Universität & StudiumSeller's business information
AHA-BUCH GmbH
Garlebsen 48
Einbeck, Germany 37574
Terms of sale
Imprint
Seller Info:
AHA-BUCH GmbH
represented by the managing director Christel Glass
Garlebsen 48
37574 Einbeck
Deutschland
Telefon: 055639996039
Telefax: 055639995974
E-Mail: abebooks@aha-buch.de
USt-IdNr.: DE261904229
registered at Commercial register Amtsgerichtes Göttingen
Handelsregisternummer HRB 200691
Alternative dispute resolution:
The European Commission provides a platform for out-of-court online dispute resolution (ODR platform), which can be accessed under https://ec.europa.eu/odr.
We have been a member of the "FairCommerce" initiative since 25.05.2018.
For more information, see www.fair-commerce.de.
Right of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to AHA-BUCH GmbH, Einbeck, Germany, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.
Shipping terms
We ship your order after we received them
for articles on hand latest 24 hours,
for articles with overnight supply latest 48 hours.
In case we need to order an article from our supplier our dispatch time depends on the reception date of the articles, but the articles will be shipped on the same day.
Our goal is to send the ordered articles in the fastest, but also most efficient and secure way to our customers.