EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation

 
• By Vibha Sharma

A new Q&A document clarifies the interface between the EU regulations on clinical trials and in vitro diagnostics to support the coordinated assessment of studies involving the use of diagnostic assays.

Biomarker DNA Strand Medical Research 3d Illustration
Companion diagnostics can support the safe and effective use of a drug by identifying patients more suited to the treatment • Source: Shutterstock

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