Drug/Diagnostic R&D Guidance Will Accommodate Biomarker Data Diversity
This article was originally published in The Gray Sheet
A retrospective study approach to drug and diagnostic co-development may be appropriate to verify a test's clinical utility in certain cases, FDA notes in a draft concept paper
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Draft document addresses how FDA expects drugs and devices to be developed contemporaneously and how those products will be reviewed simultaneously by the relevant regulatory centers at FDA with collaboration across divisions.
Industry is anxiously awaiting guidance from FDA on the development of companion diagnostics for drugs that will inform efforts to move towards personalized medicine.
FDA is trying to build flexibility into its drug/diagnostic co-development guidance to address variability in how and when therapeutics and companion diagnostics are developed