Details
Softbound | 256 pages
Print ISBN | 978-1-935065-89-0
E-Book ISBN | 978-1-935065-90-6
Overview
As dramatically illustrated by the COVID-19 pandemic, In Vitro Diagnostics (IVDs) play a central and growing role in the health care system. These products—whether for infectious diseases, cancer, or any other condition—present both opportunities to advance public health and regulatory challenges. FDLI’s practical guidebook, Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment, explores these regulatory issues and provides insights from leading experts on how to address them.
This book covers the key regulatory topics for IVDs, providing both guidance that can help IVD companies succeed and perspectives on critical policy issues. Topics include the history of IVD regulation, regulatory strategies for applicants, pre-market pathways, clinical trials, analytical testing, complying with quality system regulation, post-market regulation, EUAs, complementary and companion diagnostics, LDT, CLIA, EU regulation, and proposed federal legislation.
Containing sixteen chapters written by top practitioners in the field, this book serves as an invaluable single reference for helping to navigate the complex regulatory landscape of in vitro diagnostics.
We are experiencing shipment delays. We encourage individuals to consider our e-book options, which are usually available within one business day.
Purchase
Member
$129
Non-Member
$159
Student
$99
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FAQs
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Related Resource
The Impact of COVID-19 on the In Vitro Diagnostic Industry
Recorded April 8, 2021 | On-Demand Webinar
