Login to Your Account

FDA draft seeks to clarify policy on drug study IVDs

By Mark McCarty
Regulatory Editor

Monday, December 18, 2017

With the age of the companion diagnostic fast approaching, the FDA recently issued a draft guidance dealing with the use of investigational in vitro diagnostics (IVD) in drug studies, highlighting the circumstances in which the use of that IVD rises from an insignificant to a significant risk, thus incurring a regulatory liability.

To continue reading subscribe now to Latest News

Learn More about Latest News

Already a subscriber? Sign In or Buy now to activate your subscription