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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 That is among the issues that will be addressed in an upcoming co-development draft guidance.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Industry groups commenting on the agency’s companion diagnostics draft guidance, released in July, have expressed concern that the wording of the draft would in many cases require sponsors to get both

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