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Industry Publishes Key Proposals For Development Of Companion Diagnostic Guidance

 
• By Amanda Maxwell

Companion diagnostics are being regulated Europe-wide for the first time under the IVD Regulation which fully applies on 26 May 2022. Industry is calling for details and guidance on how this will work.

Signpost

A joint pre-submission advice and consultation procedure for EU manufacturers of companion diagnostics is needed as a growing matter of urgency, given that these products will be regulated Europe-wide for the first time under the forthcoming IVD Regulation.

Appropriate guidance on this should be developed as soon as possible by the European Medicines Agency (EMA), together with notified...

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