FDA Releases Companion Dx Guidance Broad In Scope, Limited In Detail
FDA released long-awaited draft guidance on the development of drugs with companion diagnostics July 12, but the 12-page document’s concise nature left some in the industry longing for more insight.
You may also be interested in...
Dx assays Pte. Ltd. says its fee-for-service business model makes it a unique provider of companion diagnostics in a market set to boom globally as U.S. FDA and other regulators push for drug firms to develop diagnostics alongside drugs.
The sensitivity and specificity of the target identification could determine size of the off-target population, CDER senior statistical advisor Robert O’Neill says at DIA/FDA meeting on revitalizing R&D.
A Center for Devices and Radiological Health representative tells a conference on drug/diagnostic co-development that it doesn’t matter how well designed a study for a therapeutic agent is if the accompanying biomarker-targeted test is not reliable and uniformly implemented.