Navigating the FDA Regulatory Processes

An Integrated Clinical and Engineering Approach

By: Yitzhak Rosen (Editor), Pablo Gurman (Editor), Noel Elman (Editor)

Write A Review

eText | 31 January 2025 | Edition Number 1

At a Glance

Format
ePUB

eText

$249.70

or 4 interest-free payments of $62.42 with

Instant online reading in your Booktopia eTextbook Library *

Why choose an eTextbook?

Instant Access *

Purchase and read your book immediately

Read Aloud

Listen and follow along as Bookshelf reads to you

Study Tools

Built-in study tools like highlights and more

* eTextbooks are not downloadable to your eReader or an app and can be accessed via web browsers only. You must be connected to the internet and have no technical issues with your device or browser that could prevent the eTextbook from operating.

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.