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EMA Explains Process For Assessing Suitability Of Biomarkers With Concerned Medicines

 
• By Vibha Sharma

A new EU guideline outlines the steps that notified bodies can take to facilitate the European Medicines Agency’s assessment of the appropriateness of a companion diagnostic’s use with a drug.

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IVD Regulation makes it mandatory for companion diagnostics to undergo a conformity assessment by a notified body • Source: Shutterstock

The European Medicines Agency has issued final guidance outlining the procedure that notified bodies designated to review in vitro diagnostics (IVDs) must follow when seeking a scientific opinion on the suitability of a companion diagnostic (CDx) with the concerned medicinal product.

The guideline is expected to further support the development of CDxs or biomarkers that are a critical tool for furthering...

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