Life Sciences/FDA Alert: FDA Draft Guidance on In Vitro Companion Diagnostic Devices Provides an Outline but Few Specifics to Advance the Growth of Personalized Medicine
7/22/2011
Focusing on the Food and Drug Administration (FDA) Draft Guidance on in vitro companion diagnostic devices issued July 14, 2011, this alert describes the FDA’s efforts to facilitate the development and review of Companion Diagnostics and corresponding therapeutics. A link to the Draft Guidance on the FDA website can be found at the end of the document.
