Final FDA Genetic Test Guidelines Respond To Some Industry Critiques
This article was originally published in The Gray Sheet
Executive Summary
FDA finalized guidelines for developing gene-based tests June 19, responding to some industry concerns with a February 2006 proposal, but largely sticking with the intent of the earlier draft
You may also be interested in...
FDA Diagnostics Office Seeks Bigger Role In Personalized Medicine
FDA officials that regulate lab tests don't think they have been active enough in the policy debate over the future of personalized medicine; but, they say, that is about to change
FDA Diagnostics Office Seeks Bigger Role In Personalized Medicine
FDA officials that regulate lab tests don't think they have been active enough in the policy debate over the future of personalized medicine; but, they say, that is about to change
FDA Diagnostics Office Seeks Bigger Role In Personalized Medicine
Historically overlooked office gets leadership, money and hiring okay needed to ramp up its contribution to pan-FDA initiatives, policy discussions.