<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&ev=PageView&noscript=1">
IMARC Blog

Compliance In Focus

FILTER BY:

Newest Post

Posted by John Lehmann on Thu, Mar 24, 2016

In Vitro Diagnostics: The Basics

It has been estimated that In Vitro Diagnostics (IVD) will play a role in around 70% of health care decisions, and market estimates predict the IVD market will be close to 75 billion dollars in 2010.  The role of IVDs in health care decisions should only continue to grow as healthcare shifts away from a “one-size-fits-all” model.  Furthermore, developments in technology and the scope and precision of some of these devices have led to the evolution of the IVD field and with it, the role the FDA has played in regulating these devices. 

Topics: IVD, FDA, IMARC Research Whitepaper, In Vitro Diagnostics

Posted by Michael Marotta on Tue, Aug 11, 2015

Personalized Medicine, the FDA, and Health Care Professionals

Recently we have reviewed the role of direct-to-consumer genetic testing  within the sphere of personalized medicine.  Personalized medicine can refer to tailoring disease treatment, therapy, or prevention to a particular individual, often utilizing some of the genomic signatures that make each of us unique.  Today we will look at a recent FDA news release which looks at personalized medicine from the perspective of the health care professional in respect to two areas: in vitro diagnostic (IVD) companion devices and laboratory developed tests (LDT).

Topics: Personalized Medicine, IVD, Laboratory Developed Tests, FDA

requestconsult-bg.jpg
Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.