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CDRH’s Mansfield Addresses Upcoming Drug/Dx Co-Development Guidance

Either an IND or an IDE will be sufficient for companion diagnostic studies, a CDRH diagnostics official clarified last week. That is among the issues that will be addressed in an upcoming co-development draft guidance.

Companion diagnostic developers can use either an investigational device exemption or investigational new drug application as a means to study the assay for FDA approval, a top diagnostics official at CDRH clarified last week.

Industry groups commenting on the agency’s companion diagnostics draft guidance, released in July, have expressed concern that the wording of...

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