FDA Adjusts Thinking On Drug/Diagnostic Co-Development Draft Guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA will be more flexible about the schedule it expects sponsors to follow for drug/diagnostic co-development than the agency suggested in a 2005 "concept paper" on the subject
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
Historically overlooked office gets leadership, money and hiring okay needed to ramp up its contribution to pan-FDA initiatives, policy discussions.
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